Rey Mysterio Reveals He Has Started Stem Cell Treatment – Inside The Ropes

Rey Mysterio has shared that he and his son Dominik are both undergoing stem cell treatment. Mysterio hopes that it will allow him to live pain-free and perform like he was 25 again.

Rey Mysterio has not been seen on WWE TV since the Raw following WrestleMania 38 when he and Dominik were attacked by a debuting Veer Mahaan. The assault came after Dominik had been quickly defeated by The Miz. With Dominik gathering himself in the ring, Veer arrived on the scene to hand out some more punishment. He threw Rey to one side before locking in a modified Camel Clutch on Dominik to leave him laying.

This led to the announcement of a match between Rey Mysterio and Veer the following week, April 11th. However, the elder Mysterio was missing from the show, with Veer instead taking on and defeating Dominik in short order.

Following his absence, Dave Meltzer reported on Wrestling Observer Radio that Mysterio was suffering from an undisclosed medical issue, but could be back in a matter of weeks.

Hes a medical issue, Its not false advertising or they changed their mind. It was he was unavailable tonight. So they put Dominik in the place and Dominik just got destroyed. So, they could probably do Rey in a week or two.

Now, Rey Mysterio has taken to Instagram to tell fans that he and Dominik have both undergone stem cell treatment.

My boy @dominik_35 and I started our #StemCell treatment on Monday and today we had an incredible reception too the injections.

Big thanks too the homie David y gracias al Dr. Vallejo por cuidarnos alTiene buena mano Doc!! #CPI

On his IV bag, Mysterio has written that he hopes the treatment will let him work pain-free and perform like he was 25 years old again.

God bless these stem cells so they can do work and repair my body so I can live pain-free and perform like I was 25 again. RM 619.

At the time of writing, it is unknown when Mysterio will return to WWE TV.

Read more here:
Rey Mysterio Reveals He Has Started Stem Cell Treatment - Inside The Ropes

Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II) -…

No effective therapy exists for the most common long-term side effect of radiation therapy for head and neck cancer (HNC)xerostomia. The objective was to evaluate safety and provide proof of concept for efficacy of allogeneic adipose tissue-derived mesenchymal stem/stromal cells (AT-MSCs) injected into the major salivary glands of irradiated patients. This open-label, first-in-human, phase 1b, and single-center trial was conducted with repeated measurements days 0, 1, 5, and 30 and 4 months. Eligible patients with objective and subjective signs of radiation-induced salivary gland damage after treatment of oropharyngeal squamous cell carcinoma stages I-II (UICC 8) were enrolled. Twenty-five million cryopreserved AT-MSCs were injected into each submandibular and 50 million AT-MSCs into each parotid gland. Data were collected on adverse events, unstimulated and stimulated whole saliva (UWS and SWS) flow rates and saliva composition, patient-reported outcomes (EORTC QLQ-H&N35 and Xerostomia Questionnaire [XQ]), blood samples and salivary gland scintigraphy. Data were analyzed using repeated measures linear mixed models. Ten patients (7 men, 3 women, 59.5 years [range: 45-70]) were treated in 4 glands. No treatment-related serious adverse events occurred. During 4 months, UWS flow rate increased from 0.13 mL/minute at baseline to 0.18 mL/minute with a change of 0.06 (P= .0009) mL/minute. SWS flow rate increased from 0.66 mL/minute at baseline to 0.75 mL/minute with a change of 0.09 (P =.017) mL/minute. XQ summary score decreased by 22.6 units (P= .0004), EORTC QLQ-H&N35 dry mouth domains decreased by 26.7 (P= .0013), sticky saliva 23.3 (P= .0015), and swallowing 10.0 (P= .0016). Our trial suggests treatment of the major salivary glands with allogenic AT-MSCs is safe, warranting confirmation in larger trials.

Read more:
Intraglandular Off-the-Shelf Allogeneic Mesenchymal Stem Cell Treatment in Patients with Radiation-Induced Xerostomia: A Safety Study (MESRIX-II) -...

Newsletter April 2022 – Progress in Cline’s cell lab and in the stem cell therapy field – Marketscreener.com

Spring has arrived in Gothenburg, and the Cline is excited to bring you some exciting news and updates from our team

The first stage of Ex-vivo testing completed

Early this month, Cline announced that the first stage of our ex-vivo experiments was carried out with encouraging performance. This newsletter will take a deeper look at what's happening in our labs and what these tests mean for StemCART.

These experiments, which began in January 2022, are an important milestone for the StemCART project and will push the project into the next development stage. In these tests, Cline has several aims; 1) demonstrate that the matrix developed by Cline successfully functions, 2) the successful differentiation of induced pluripotent stem cells (iPSCs) into functional chondrocytes (cartilage cells), and 3) to show induced healing of the injured cartilage tissue.

To achieve this, Cline has been collaborating with orthopedic surgeons and a hospital to collect cartilage tissue from patients undergoing surgery. Cline then takes this tissue from the hospital to our cell labs. At the lab we induce an artificial cartilage damage to mimic joint injuries before implanting the cells and matrix together at the injury site.

In this first stage of testing, the supporting matrix demonstrated the expected functionality in successfully fixing cells to the area of interest.

Read more about this in our latest press release or where Cline was recently featured on ORTHOWORLD.

Next steps for StemCART

The ex-vivo tests continues and Cline will carry out at least 24 further experiments in several stages. The results from these will be communicated after the completion of each stage. The upcoming stage of 10 experiments will test a higher cell concentration and focus on determining the functionality of the chondrocytes. Testing will also be expanded to include tissue of different cartilage origin, such as knee, shoulder, and hip.

StemCART's ultimate vision is as a cell-based Advanced Therapy Medical Product (ATMP) that will revolutionize the treatment of cartilage damage by providing patients with new functional cartilage and curing the condition, thus eliminating pain. StemCART provides several advantages over other therapy strategies such as autologous chondrocytes implantation and mesenchymal stem cells (MSCs) in that it provides reparative cartilage to the joint, and that an allogeneic cell source has much better scalability.

As part of the journey to this goal, Cline will continue preparing for in-human clinical trials, including scaling up production in a GMP facility together with partners, developing QA/QC methods, as well as the necessary safety testing and documentation for a clinical trial application. Cline has begun this work by evaluating different development and manufacturing options and engaging in regulatory pathway strategic planning activities.

Cline envisions out-licensing StemCART to a commercial partner following successful phase I trials. The process to identify and engage potential partners is ongoing, with the aim of generating interest in the commercialization of StemCART.

Exciting industry news and developments

2022 has already been an exciting year in the world of stem cell-based therapy and cartilage repair, showing the increasing interest and potential paradigm shift towards cell-based treatment. For example in the MSC segment, the Lund-based company Xintela recently began its first-in-human clinical trial for mesenchymal stem cells (MSC) in knee osteoarthritis (OA). Similarly, Cynata Therapeutics, working with iPSC-derived MSCs to treat knee OA, together with Fujifilm Cellular Dynamics, is currently conducting a large phase III trial. For more insights into the current landscape of cartilage repair treatments and current status of new cell-based treatments, you can read Cline Scientific's latest publication, "Insights into the present and future of cartilage regeneration and joint repair," available at https://www.mdpi.com/journal/ijms/special_issues/Cartilage_Repair.

Another leap forward for iPSC-derived tissue therapy is the conclusion of a world-first clinical trial, showing that implanting iPSC-derived corneal tissue into four nearly blind patients was safe and effective. The team from Osaka University used iPS cells to create the cornea tissue, which caused improvement of symptoms and eyesight and did not lead to any rejection or tumorigenicity.

Finally, in related orthopedic industry news, Bioventus acquired its partner CartiHeal for up to 450M USD. CartiHeal is an orthopedic device company that has developed the cartilage repair implant Agili-C, which was recently approved by the FDA. Agili-C is a cell-free scaffold implant for cartilage and osteochondral defects caused by either osteoarthritis or trauma.

We look forward to continuing to share Cline's journey in future newsletters!

Warmest regards,

The Cline Team

Click hereto subscribe to future newsletters and press releases. https://news.cision.com/cline/SubscriptionRegistrationDialog

Cline Scientific AB (publ) Telefon: 031-387 55 55 Argongatan 2 C E-post: info@clinescientific.com 431 53 MLNDAL Hemsida: http://www.clinescientific.com

About Cline Scientific Cline Scientific develops advanced cancer diagnostics and regenerative medicine treatments. The company is working heavily with R&D through joint collaborations with pharmaceutical companies and academic researchers around the world. The focus is on projects in the cancer diagnostic and stem cell therapy fields since Clines nanotechnology here provides unmet solutions to critical challenges and functions. The unique patented surface nanotechnology is used in cell-based products and processes to drive projects within Life Science into and through the clinical phase.

https://news.cision.com/cline/r/newsletter-april-2022---progress-in-cline-s-cell-lab-and-in-the-stem-cell-therapy-field,c3555837

https://mb.cision.com/Main/12114/3555837/1571081.pdf

(c) 2022 Cision. All rights reserved., source Press Releases - English

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Newsletter April 2022 - Progress in Cline's cell lab and in the stem cell therapy field - Marketscreener.com

Bone Therapeutics announces 2021 full year results – GlobeNewswire

REGULATED INFORMATION

Strategic focus revised and fully focused on achieving topline results of the ALLOB Phase IIb study in tibial fractures.

Discussions for ALLOB global partnership still ongoing.

Board of Directors and Management exploring all strategic options to protect shareholder value.

Strengthening financial position with EIB agreement and private placement in 2021 and a new bond issuance foreseen in May 2022

Management to host conference call today at 3pm CEST / 9am EST - details provided below

Mont-Saint-Guibert, Belgium, 29April 2022, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update and full year financial results for the year ending 31 December 2021, prepared in accordance with IFRS as adopted by the European Union.

Incomplete fracture healing remains a seriously unmet medical need affecting hundreds of thousands of patients worldwide. Despite the pandemic and subsequent seriously geopolitical and economic global events, Bone Therapeutics still remains on target for delivery of topline results for its Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures, said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. We believe ALLOB could provide difficult tibial fracture patients a convenient treatment option with a potentially superior outcome. Having successfully completed two clinical studies showing promising safety profile and efficacy signals in more than 60 patients, we firmly believe that ALLOB has the highest potential of near-term value creation and is focused on completing the current Phase IIb study. In addition, Bone Therapeutics has made a serious contribution for the future into the use of Induced Pluripotent Stem Cell (iPSC) derived, genetically engineered MSCs. Bone Therapeutics is continuing its efforts to establish value adding business collaborations and to strengthen its financial position.

Clinical and operational highlights (including post-period events)

In January 2021, Bone Therapeutics initiated the treatment of patients in the Phase IIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. Bone Therapeutics anticipates finalizing patient recruitment of this study in 2022. This recruitment finalization is subject, as across the industry, to evolution of the ongoing COVID-19 pandemic and the associated containment measures. Although early recruitment rates were very promising, the recruitment rates have temporarily slowed in subsequent months due to pandemic-related factors, such as reduced site activities due to staff availability and the number of available patients due to less occurrence of accidents. Bone Therapeutics has implemented several mitigating measures in collaboration with the involved clinical research organization to improve and facilitate recruitment. These measures include site expansion, training, information, best practices sharing and close monitoring of progress. As a result of these measures and the improving recruitment rate, Bone Therapeutics continues to currently expect the release of topline data by Q1 2023.

In January 2021, Bone Therapeutics signed an initial agreement for a process development partnership with the mesenchymal stromal cell (MSC) specialist, Rigenerand. This collaboration focused on further developing and enhancing Bone Therapeutics bone-forming platform.

In June 2021, Bone Therapeutics published the positive results of its Phase I/IIa clinical trial with ALLOB in patients with delayed union fractures. The results were published in Stem Cell Research & Therapy, the international peer-reviewed journal focusing on translational research in stem cell therapies. ALLOB was generally well-tolerated and that all patients met the primary endpoint.

In August 2021, Bone Therapeutics announced topline results from the Phase III knee osteoarthritis study with its enhanced viscosupplement JTA-004, its legacy non-MSC product. JTA-004 had a favorable safety profile. However, the study did not meet the primary and key secondary endpoints. No statistically significant difference in pain reduction could be observed between the treatment, placebo and comparator groups, with all treatment arms showing similar efficacy.

In September 2021, Bone Therapeutics signed a research evaluation agreement with Implant Therapeutics, the developer of hypoimmunogenic and safe harbor engineered IPSC derived cells. The agreement enables Bone Therapeutics to access, evaluate and materially transfer Implant Therapeutics Induced Pluripotent Stem Cell (iPSC) derived, genetically engineered MSCs, including lines, media, differentiation protocols and expertise.

In November 2021, Bone Therapeutics signed a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics allogeneic osteoblastic cell therapy product, with one of its current Chinese partners, Link Health Pharma Co., Ltd (Link Health). The negotiations for the global rights agreement are still ongoing but take longer than expected. The envisaged completion of a final binding agreement has been delayed and is now contemplated over the course of Q2 2022.

Corporate highlights (including post-period events)

In March, 2021, Bone Therapeutics appointed the stem cell therapy industry veteran, Anthony Ting, PhD, as Chief Scientific Officer. Dr. Ting is responsible for Bone Therapeutics research activities.

In July 2021, Bone Therapeutics appointed Dr. Anne Leselbaum as Chief Medical Officer. Dr. Leselbaum brings three decades of experience in strategic international clinical development, clinical operations and medical affairs. As CMO, she takes responsibility for the leadership of all clinical development and medical affairs strategies and activities across the entire Bone Therapeutics pipeline and will oversee the regulatory interactions.

In September 2021, Bone Therapeutics appointed Lieve Creten, as interim Chief Financial Officer (CFO), succeeding Jean-Luc Vandebroek. Lieves extensive financial experience ensures the continued optimal financial control, oversight and compliance.

In October 2021, Bone Therapeutics appointed key experts to its Scientific Advisory Board (SAB). The members of the SAB consist of world-recognized scientists and clinicians in the cell and gene therapy field.

In March 2022, Bone Therapeutics announced it was redefining its strategic priorities to concentrate specifically on the development of its most advanced clinical asset, ALLOB. As a result, Bone Therapeutics will focus its R&D activities to support the clinical development of ALLOB and all activities related to the development of the pre-clinical iMSCg platform as well as all other non ALLOB related activities, were stopped. In this context, some members of Bone Therapeutics' management team will depart Bone Therapeutics in the following months in alignment with the refocus in activity. This includes Miguel Forte (CEO), Tony Ting (CSO), Stefanos Theoharis (CBO) and Lieve Creten (CFO). During the transition, CEO, Miguel Forte, will remain in function. The Scientific Advisory Board was also dissolved.

Financial highlights (including post-period events)

In July 2021, Bone Therapeutics secured a loan agreement of up to 16.0 million with the European Investment Bank (EIB). The EIB loan financing will be disbursed in two tranches of 8.0 million each, subject to conditions precedent. Following the approval of the issuance of associated warrants by Bone Therapeutics General Meetings at the end of August 2021, Bone Therapeutics received a payment from the EIB for the first tranche of 8.0 million and the EIB was granted 800,000 warrants approved by the Extraordinary General Meeting.

In August 2021, Bone Therapeutics also renegotiated 800 convertible bonds issued on May 7, 2020 (for an amount of 2 million) to Patronale Life into a loan subject to the same repayment terms as the agreement with the EIB, with the issuance of 200,000 additional warrants approved by the Extraordinary General Meeting.

In December 2021, Bone Therapeutics raised additional 3.3 million funding through a private placement with current and new institutional investors to advance its lead orthopedic asset, ALLOB, through mid-stage clinical development.

The total revenues and operating income for 2021 amounted to 2.7 million compared to 3.7 million in 2020. As a result of the reduced clinical activities following the completion of the Phase III JTA-004 study, and the slower pace of patient enrollment for the ALLOB TF2 Phase IIb study due to the COVID-19 pandemic, operating loss for the period decreased to 12.0 million from 15.0 million for the full year 2020. Consequently, cash used for operating activities amounted to 12.8 million for the full year 2021. Year-end cash position amount to 9.5 million compared to 14.7 million year-end 2020.

In April 2022, Bone Therapeutics signed a binding term sheet for a 5 million convertible bonds (CBs) facility arranged by ABO Securities. The proceeds of the financing will be used to advance the clinical development of Bone Therapeutics lead asset, the allogeneic bone cell therapy, ALLOB. ABO Securities, on behalf of the CB investor, commits to subscribe to up to 5 million in CBs. Subject to the fulfillment of condition precedents, Bone Therapeutics and ABO Securities aim to agree on and execute the final subscription agreement for the CBs and to issue the first tranche of CBs by the beginning of May 2022.

Outlook for the remainder of 2022

In the ongoing Phase IIb ALLOB clinical study in difficult tibial fractures, Bone Therapeutics clinical team, in partnership with its clinical research organization, is continuing to institute measures to mitigate the impact of the pandemic and will closely monitor the recruitment progress. As a result of the initial mitigation actions and the improving recruitment rate due to the gradual lifting of COVID-19 related measures in Europe, Bone Therapeutics expects to report topline results as scheduled by the first quarter of 2023. However, a delay cannot be excluded. Should the pandemic continue to have impact on patient availability, Bone Therapeutics may have to re-evaluate this timeline and, in that eventuality, will communicate again to the market.

The negotiations for ALLOB, with one of Bone Therapeutics current Chinese partners, for the global rights agreement are still ongoing but are taking longer than originally anticipated. The potential completion of a final binding agreement has been delayed into Q2 2022.

Subsequent to some preliminary contacts, the board of directors of Bone Therapeutics is currently examining various opportunities to combine certain activities within Bone Therapeutics, taking into account the interests of its shareholders and other stakeholders. Further announcements will be made in due course, if and when circumstances so allow or require.

Following the restructuring of the management team announced on 12 April 2022, Bone Therapeutics has initiated the search for a new CEO and CFO.

Disciplined cost and cash management will remain a key priority. The operating cash burn for the full year 2022 is expected to be in the range of 8-10 million, assuming normal operations as the effect of the ongoing COVID-19 epidemic cannot be excluded. The situation will be actively and closely monitored. The company anticipates having sufficient cash to carry out its business objectives into Q1 2023, assuming, amongst other, full issuance of the new convertible bond facility. Bone Therapeutics refers to the going concern statement in the Annual Report 2021 for all key assumptions taken.

Conference call

Miguel Forte, MD, PhD, Chief Executive Officer will host a webcast with conference call today at 3:00 pm CEST / 9:00am EST. To participate in webcast or the conference call, please use the following link:

https://us06web.zoom.us/j/81633950602

Or select your dial-in number from the list below quoting the conference ID 816 3395 0602#:

Belgium: +32 2 290 9360 France: +33 1 7095 0103 United Kingdom: +44 208 080 6592 United States: +1 646 876 9923

The presentation will be made available on the Investors section - Presentations of the Bone Therapeutics website shortly prior to the call.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. Currently Bone Therapeutics is concentrating specifically on the development of its most advanced clinical asset, the allogeneic cell therapy platform, ALLOB.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell and gene therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Its leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SA Miguel Forte, MD, PhD, Chief Executive Officer Lieve Creten, Chief Financial Officer ad interim Tel: +32 (0)71 12 10 00 investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries: Bepublic Bert Bouserie Tel: +32 (0)488 40 44 77 bert.bouserie@bepublicgroup.be

International Media Enquiries: Image Box Communications Neil Hunter / Michelle Boxall Tel: +44 (0)20 8943 4685 neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries: NewCap Investor Relations & Financial Communications Pierre Laurent, Louis-Victor Delouvrier and Arthur Rouill Tel: +33 (0)1 44 71 94 94 bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Excerpt from:
Bone Therapeutics announces 2021 full year results - GlobeNewswire

Gamida Cell Presents Updated One-Year Post-Transplant Follow Up Data from Phase 3 Study of Omidubicel at 2022 Transplantation & Cellular Therapy…

Omidubicel is a first-in-class, advanced NAM-enabled stem cell therapy candidate with breakthrough and orphan drug designations being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant

Updated data from oral presentation demonstrates overall survival trend due to early engraftment and lower infections with omidubicel

Concludes that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared with standard UCB

BOSTON, April 27, 2022--(BUSINESS WIRE)--Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today announced updated one-year post-transplant data presented on omidubicel at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022.

In an oral presentation titled "Allogeneic Hematopoietic Stem Cell (allo-HSCT) Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT): Final Results of a Phase III Randomized, Multicenter Study," Mitchell Horwitz, M.D., Professor of Medicine, Duke Cancer Institute, shared one-year post-transplant follow up data from the omidubicel Phase 3 trial. The data showed sustained clinical benefits in the first-year post-transplant with omidubicel, as demonstrated by significant reduction in infectious complications. Results also showed reduction in non-relapse mortality and no significant increase in relapse rates with omidubicel, compared to UCBT (23% vs. 18%). It was concluded that HSCT with omidubicel results in rapid hematopoietic recovery, reduced rates of infections and no increase in GvHD rates compared with standard UCB. There was a continued trend toward improved OS in favor of the omidubicel arm over time (73% vs. 60%). The overall and sustained clinical benefit of omidubicel makes it an important addition to the options for allogeneic HSCT.

Story continues

"In allo-HSCT, early engraftment and lower infections are the key predictors of long-term success for patients," said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell, "We are encouraged by the continuous positive and sustained results from patients involved in the Phase 3 trial of omidubicel, now one-year out from treatment. These results provide promising rationale that omidubicel could become a compelling treatment option for patients in need of an allo-HSCT transplant."

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.

In total, Gamida Cell is presenting two oral and six poster presentations at TCT 2022, including an oral presentation that was selected as a TCT Best Abstract. All poster presentations are publicly available at http://www.ASTCT.org.

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.

About Gamida Cell

Gamida Cell is pioneering a proprietary NAM-enabled immunotherapy pipeline of diverse potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information on Gamida Cell, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including GDA-201), anticipated regulatory filings and the potentially life-saving or curative therapeutic and commercial potential of omidubicel. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220427005019/en/

Contacts

For investors: Courtney Turiano Stern Investor Relations, Inc. courtney.turiano@sternir.com 1-212-362-1200

For media: Rhiannon Jeselonis Ten Bridge Communications rhiannon@tenbridgecommunications.com 1-978-417-1946

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Gamida Cell Presents Updated One-Year Post-Transplant Follow Up Data from Phase 3 Study of Omidubicel at 2022 Transplantation & Cellular Therapy...

Researchers share insights about the mechanisms of human embryo and create method to develop transcriptionally similar cells in tissue culture -…

Paper Title: Identification of a retinoic acid-dependent hemogenic endothelial progenitor from human pluripotent stem cells

Journal: Nature Cell Biology

Authors:Christopher Sturgeon, PhD, Associate Professor of Cell, Developmental & Regenerative Biology and Medicine, Hematology & Medical Oncology in the Black Family Stem Cell Institute at the Icahn School of Medicine at Mount Sinai, and other coauthors.

Bottom Line:Blood-forming stem cells found in bone marrow are the life-saving component used in bone marrow transplants. However, suitable donors often cannot be found in many cases. This study reveals how the human embryo develops the precursor to blood forming stem cells, which researchers say can be used in the novel method they developed to generate blood-forming stem cells from cells in tissue culture.

The studyled by researchers from Mount Sinai and the San Raffaele Telethon Institute for Gene Therapy in Milan Italyconfirms many aspects of cell development, including origins and regulation, which are known to occur within both the mouse and human embryo. In the mammalian embryo, blood-forming stem cells emerge from a specialized cell type called hemogenic endothelium. These cells develop in response to a critical signal pathway known as retinoic acid, which is essential for growth. Their analysis found that stem cell populations derived from human pluripotent stem cells were transcriptionally similar to cells in the early human embryo.

Results: For years, researchers in the field of regenerative medicine have been able to obtain hemogenic endothelium from embryonic stem cells, but these cells do not produce blood-forming stem cells. In the embryo, blood-forming stem cell development requires signaling by retinoic acid.But, current state-of-the-art methods for deriving blood progenitors from human pluripotent stem cells do so in the absence of retinoic acid. In this latest study, researchers examined the dependence on retinoic acid in early cell types derived from human pluripotent stem cells. They performed single cell RNA sequencing of stem cells in vitro to better understand patterns of mesodermal cell types during early development. The research team identified a new strategy to obtain cells that are transcriptionally similar to those hemogenic endothelial cells found in the human embryo by stimulating a very discrete original population with retinoic acid.

Why the Research Is Interesting:This new method brings researchers and scientists closer to developing blood-forming stem cells in tissue culture, but also provides a pathway to establishing specialized blood cell types for transfusions and other treatments for cancer since the new method makings it possible to obtain the same original cells in adult blood that are found in a developing embryo.

Said Mount Sinai's Dr. Christopher Sturgeon of the research: We have made a major breakthrough in our ability to direct the development of stem cells in a tissue culture dish into cells that have the same gene expression signature as the immediate progenitor of a blood-forming stem cell found in the developing embryo. With this, now we can focus our efforts at understanding how to capture embryonic blood-forming stem cells, with the goal of using them as a substitute for bone marrow.

Researchers from the Washington University School of Medicine in St. Louis, MO contributed to this study.

###

To request a full copy of the paper or to schedule an interview with the researcher, please contact the Mount Sinai Press Office at stacy.anderson@mountsinai.org or 347-346-3390.

Nature Cell Biology

28-Apr-2022

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Researchers share insights about the mechanisms of human embryo and create method to develop transcriptionally similar cells in tissue culture -...

Gene Therapy Team Wins Grant to Further Research on Rare SYNGAP-1 Genetic Disorder – Genetic Engineering & Biotechnology News

The SynGAP Research Fund (SRF) awarded a $128,000 grant to Joseph Anderson, PhD, associate director of the University of California-Davis Gene Therapy Center and associate professor at UC-Davis. Based on the studyFunctional rescue in an Angelman syndrome model following treatment with lentivector transduced hematopoietic stem cells in Human Molecular Genetics, Anderson will test the same approach in an animal model of SYNGAP1 and evaluate for functional rescue of related phenotypes.

SYNGAP1-related intellectual disability is a rare genetic disorder caused by a variation on the SYNGAP1 gene, with over 1,000diagnosed patients accounted for globally as of March 2022. It leads to several neurological issues in patients, including intellectual disability, epilepsy, autism, sleep challenges, gastro-intestinal and feeding problems, hypotonia (low muscle tone), apraxia (delayed/no speech), impulsivity and aggression.

For our current research, we will be evaluating whether a hematopoietic stem cell gene therapy approach is effective in rescuing phenotypes observed in an animal model of SYNGAP1, says Anderson. Based on the results we observed in our project for Angelman Syndrome, we are excited to apply this strategy to SynGAP as well.

In our current proposal, we will be gene modifying blood-forming stem cells with a vector that expresses wild type and functional SYNGAP1. These cells will be transplanted in an animal model of SynGAP and be evaluated for rescue of SynGAP-related phenotypes.

We will also be evaluating whether successful expression of SYNGAP1 can be detected in the brains of the transplanted animals. This work, if successful, will bring this therapeutic strategy closer to a clinical trial. We are currently evaluating a similar strategy for the treatment of other neurodevelopmental disorders.

According to Michael Graglia, managing director of SRF, the fund closely watches leading rare disease groups to identify opportunities to help individuals with the genetic disorder.

When theFAST-fundedwork was announced, we immediately sought to test it for SYNGAP1, just asRSRT is doing for Rett, he adds.

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Gene Therapy Team Wins Grant to Further Research on Rare SYNGAP-1 Genetic Disorder - Genetic Engineering & Biotechnology News

Global Stem Cell Market To Be Driven By Increasing Activities To Use Stem Cells In Regenerative Medicines In The Forecast Period Of 2022-2027 …

The new report by Expert Market Research titled, Global Stem Cell Market Report and Forecast 2022-2027, gives an in-depth analysis of the globalstem cell market, assessing the market based on its segments like types, treatment types, applications and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report summary@https://www.expertmarketresearch.com/reports/stem-cell-market/requestsample

The key highlights of the report include:

Market Overview (2017-2027)

The stem cell business is growing due to an increase in activities to use stem cells in regenerative treatments due to their medicinal qualities. The increasing use of human-induced pluripotent stem cells (iPSCs) for the treatment of hereditary cardiac difficulties, neurological illnesses, and genetic diseases such as recessive dystrophic epidermolysis bullosa (RBED) is driving the market forward.

Furthermore, because human-induced pluripotent stem cells (iPSCs) may reverse immunosuppression, they serve as a major source of cells for auto logic stem cell therapy, boosting the industrys expansion. Furthermore, the rising incentives provided by major businesses to deliver breakthrough stem cell therapies, as well as the increased use of modern resources and techniques in research and development activities (R&D), are propelling the stem cell market forward.

Because of increased research and development (R&D) in the United States and Canada, North America accounts for a significant portion of the overall stem cell business. Furthermore, the increased frequency of non-communicable chronic diseases such as cancer and Parkinsons disease, among others, is boosting the use of stem cell therapy, boosting the industrys growth. Furthermore, the regions stronghealthcaresector is improving access to innovative cell therapy treatments, assisting the regional stem cell industrys expansion. Aside from that, due to the rising use of regenerative treatments, the Asia Pacific area is predicted to rise rapidly. Furthermore, rising clinical trials are assisting market expansion due to low labour costs and the availability of raw materials in the region, contributing considerably to overall industry growth.

Industry Definition and Major Segments

A stem cell is a type of cell that has the ability to develop into a variety of cells, including brain cells and muscle cells. It can also help to repairtissuesthat have been injured. Because stem cells have the potential to treat a variety of non-communicable and chronic diseases, including Alzheimers and diabetes, theyre being used in medical and biotechnological research to repair tissue damage caused by diseases.

Explore the full report with the table of contents@https://www.expertmarketresearch.com/reports/stem-cell-market

The major product types of stem cell are:

The market can be broadly categorised on the basis of its treatment types into:

Based on applications, the market is divided into:

The EMR report looks into the regional markets of stem cell-like:

Market Trends

The market is expected to rise due to increased research activity in regenerative medicine and biotechnology to personalise stem cell therapy. The usage of stem cells is predicted to increase as the need for treatment of common disorders, such as age-related macular degeneration (AMD), grows among the growing geriatric population. Due to multiple error bars during research operations, it becomes extremely difficult to characterise cell products because each cell has unique properties. As a result, the integration of cutting-edge technologies such as artificial intelligence (AI), blockchain, and machine learning is accelerating. Artificial intelligence (AI) is being used to analyse images quickly, forecast cell functions, and classify tissues in order to identify cell products, which is expected to boost the market growth.

With the rising frequency of cancer and cancer-related research initiatives, blockchain technology is increasingly being used to collect and assimilate data in order to improve access to clinical outcomes and the latest advances. Blockchain can also help with data storage for patients while improving the cost-effectiveness of cord-blood banking for advanced research and development (R&D) purposes. In addition, the use of machine learning techniques to analyse photos and infer the relationship between cellular features is boosting the market growth. The increased interest in understanding cellular processes and identifying critical processes using deep learning is expected to move the stem cell business forward.

Latest News on Global Stem Cell Market@https://www.expertmarketresearch.com/pressrelease/global-stem-cell-market

Key Market Players

The major players in the market are Pluristem Therapeutics Inc., Thermo Fisher Scientific Inc., Cellular Engineering Technologies, Merck KGaA, Becton, Dickinson and Company, and STEMCELL Technologies Inc The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

At Expert Market Research, we tailor our approach according to our clients needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

Media Contact

Company Name: EMR Inc. Contact Person: Sofia Williams, Corporate Sales Specialist U.S.A. Email: sales@expertmarketresearch.com Toll Free Number: +1-415-325-5166 | +44-702-402-5790 Address: 30 North Gould Street, Sheridan, WY 82801, USA City: Sheridan State: Wyoming Country: United States Website: https://www.expertmarketresearch.com

IntroducingProcurement ResourcesServices of EMR Inc.

*We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Global Stem Cell Market To Be Driven By Increasing Activities To Use Stem Cells In Regenerative Medicines In The Forecast Period Of 2022-2027 ...

Jasper Therapeutics Announces Updated Data from Phase 1 Clinical Trial of JSP191 as Targeted Stem Cell Conditioning Agent in Older Patients with…

Jasper Therapeutics

JSP191 is well tolerated with no treatment-related severe adverse events in 24 patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) in Ph1b dose expansion study

24 of 24 patients achieved successful engraftment with neutrophil recovery

20 of 24 patients determined to be free from morphologic relapse or disease progression at last follow up

REDWOOD CITY, Calif., April 26, 2022 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc., (NASDAQ: JSPR) a biotechnology company focused on hematopoietic stem cell therapies, today announced updated efficacy, safety and pharmacokinetic data from its ongoing multicenter Phase 1 clinical trial of JSP191, the companys first-in-class anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation.

Updated data from the multicenter study showed that conditioning with a single dose of JSP191 0.6 mg/kg prior to low dose radiation and fludarabine in preparation for transplantation was well tolerated and led to successful engraftment as evidenced by primary neutrophil recovery and full donor myeloid chimerism in twenty-four older patients (aged 62-79) with AML in complete response (CR) or MDS. Twenty patients were determined to be free from morphological relapse or disease progression at last follow up with four patients off study due to relapse or progression. Clearance of measurable residual disease (MRD) was observed in 12 of 20 evaluable patients at last follow up. One case of late-onset grade III-IV acute GI graft vs. host disease (GVHD) and one case of secondary graft failure were reported. No JSP191 related Significant Adverse Events, no cases of classical acute grade II-IV GVHD and no cases of transplant related mortality within 100 days were reported.

The findings were presented by lead investigator Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine, as a late-breaking abstract at the 2022 Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR).

Story continues

We are excited about the progress of JSP191 as a targeted conditioning agent in patients with MDS or AML in CR undergoing hematopoietic stem cell transplant. These data show that JSP191 may be safely used on top of a standard conditioning regimen in older patients unable to tolerate myeloablative conditioning, said Ronald Martell, President and CEO of Jasper Therapeutics. We are looking forward to the start of a registration clinical study of JSP191 for transplant conditioning in MDS or AML in CR patients and the potential to bring safer and more effective conditioning to the growing population of older patients in need of blood stem cell transplant.

The Phase I trial is an open-label, multicenter study evaluating the safety, tolerability and efficacy of adding JSP191 to the standard conditioning regimen of low-dose radiation and fludarabine in patients aged 60 or older with MDS or AML undergoing hematopoietic cell transplantation. Patients were ineligible for myeloablative conditioning. The primary outcome measure of the study is the safety and tolerability of JSP191 as a conditioning regimen up to one year following a donor cell transplant. Secondary endpoints include engraftment and donor chimerism, MRD clearance, non-relapse mortality, event-free survival, and overall survival.

For more information on the study, refer to Clinicaltrials.gov identifier NCT04429191

About MDS and AML

Myelodysplastic syndromes are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells. In about one in three patients, MDS can progress to AML, a rapidly progressing cancer of the bone marrow cells. Both are diseases of the elderly with high mortality. Each year, about 29,000 patients are diagnosed with MDS and approximately 42,000 patients are diagnosed with AML in the G7 countries for which approximately 2,500 patients with MDS and approximately 8,000 people with AML receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current intensive conditioning agents that have many off-target toxicities, which includes the chemotherapy agents busulfan and melphalan.

About Jasper Therapeutics

Jasper Therapeutics is a biotechnology company focused on the development of novel curative therapies based on the biology of the hematopoietic stem cell. The company is advancing two potentially groundbreaking programs. JSP191, an anti-CD117 monoclonal antibody, is in clinical development as a conditioning agent that clears hematopoietic stem cells from bone marrow in patients undergoing hematopoietic cell transplantation. It is designed to enable safer and more effective curative allogeneic hematopoietic cell transplants and gene therapies. Clinical study of JSP191 as a novel, disease-modifying, therapeutic for patients with lower risk MDS is also planned to begin in 2022. In parallel, Jasper Therapeutics is advancing its preclinical mRNA hematopoietic stem cell platform, which is designed to overcome key limitations of allogeneic and autologous gene-edited stem cell grafts. Both innovative programs have the potential to transform the field and expand hematopoietic stem cell therapy cures to a greater number of patients with life-threatening cancers, genetic diseases and autoimmune diseases than is possible today. For more information, please visit us at jaspertherapeutics.com.

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future, outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding the potential benefits of hematopoietic stem cells (HSC) engraftment following targeted JSP191 conditioning in the treatment of myelodysplastic syndromes, acute myeloid leukemia, or severe combined immunodeficiency and JSP191s potential generally. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper Therapeutics and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of Jasper Therapeutics. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper Therapeutics develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Jasper Therapeutics product candidates; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper Therapeutics will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that final study data may not be consistent with preliminary study data; the risk that Jasper Therapeutics product candidates may not be beneficial to patients or successfully commercialized; the risk that Jasper Therapeutics has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper Therapeutics business; the risk that third parties on which Jasper Therapeutics depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper Therapeutics business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics, including the ongoing COVID-19 pandemic; the risk that Jasper Therapeutics will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others and other risks and uncertainties indicated from time to time in Jasper Therapeutics public filings with the SEC. If any of these risks materialize or Jasper Therapeutics assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Jasper Therapeutics does not presently know, or that Jasper Therapeutics currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. While Jasper Therapeutics may elect to update these forward-looking statements at some point in the future, Jasper Therapeutics specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper Therapeutics assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:

John Mullaly (investors)

LifeSci Advisors

617-429-3548

jmullaly@lifesciadvisors.com

Jeet Mahal (investors)

Jasper Therapeutics

650-549-1403

jmahal@jaspertherapeutics.com

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Jasper Therapeutics Announces Updated Data from Phase 1 Clinical Trial of JSP191 as Targeted Stem Cell Conditioning Agent in Older Patients with...

Pluristyx and Accelerated Biosciences Announce Availability of Clinical-Grade Immune-Privileged Human Trophoblast Stem Cells (hTSCs) -…

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Accelerated Biosciences ethically sourced stem cells will be available for clinical product development in Q3 2022

SEATTLE--(BUSINESS WIRE)-- Pluristyx, Inc., an advanced therapy tools and services biotechnology company, and Accelerated Biosciences, a regenerative medicine innovator in the use of proprietary human trophoblast stem cells (hTSCs), today announced they signed an agreement for Pluristyx to manufacture clinical grade hTSC banks under Good Manufacturing Practices (GMP). Accelerated Biosciences will use and make these stem cell banks available to commercial partners for further manufacturing of advanced biologic and cellular therapies. hTSCs have unique legal, ethical, and intellectual property advantages, including a high expansion capacity and a unique genetic identity not associated with any person or embryo, making them the ideal starting material for manufacturing the next generation of advanced therapies.

We are gratified by Accelerated Biosciences' choice of Pluristyx as their CDMO partner for GMP manufacturing. We are excited to be manufacturing clinical-grade cell banks for use as a unique starting source for the next generation of cell-based advanced therapies. This work demonstrates our commitment to providing the highest quality cells today for clinical development of tomorrows novel advanced therapies, said Dr. Benjamin Fryer, Chief Executive Officer of Pluristyx.

Yuta Lee, Chief Executive Officer of Accelerated Biosciences, stated: We recognized early on that there is an unmet need for an ethical, clinical-grade, pluripotent stem cell source with complete regulatory compliance documentation from donor consent to GMP release. To meet this need, we aim to make the hTSC source readily available to industry partners in order to accelerate cures to market. We are grateful to the dedicated team at Pluristyx for making this complex process simple. We look forward to doing our part to advance the cell and gene therapy industry.

About Pluristyx

Pluristyx is a privately held biotechnology company offering consulting, wet-lab and GMP banking services, and pluripotent stem cell products to support novel therapeutic developers. Pluristyx helps industry and academic researchers solve manufacturing and analytical challenges in cryopreservation, drug development, regenerative medicine, and cell and gene therapy. The Pluristyx team has decades of experience supporting every stage of cell therapy product development, from cell banking to drug product manufacturing including analytical testing and release of clinical grade cell therapy products. For more information about Pluristyx, visit http://www.pluristyx.com or email Kaye Reiter, PhD, JD at [emailprotected].

About Accelerated Biosciences

Accelerated Biosciences is a private regenerative medicine company focused on commercializing the hTSC platform, discovered by physician and researcher, Professor Jau-Nan Lee, MB, MD, PhD. Accelerated Biosciences holds a proprietary source of hTSCs with a robust intellectual property (IP) estate. Accelerated Biosciences mission is to leverage its renewable, immune-privileged human cell source to accelerate cures to patients and to make gene and cell therapy affordable to all in need. For more information about Accelerated Biosciences, visit http://www.acceleratedbio.com or email [emailprotected].

View source version on businesswire.com: https://www.businesswire.com/news/home/20220428005046/en/

Media: Kaye Reiter, PhD, JD 888-588-9935 [emailprotected]

Source: Pluristyx, Inc.

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Pluristyx and Accelerated Biosciences Announce Availability of Clinical-Grade Immune-Privileged Human Trophoblast Stem Cells (hTSCs) -...