Breath to the rescue: COVID-19 is offered to be treated with cellular inhalation – Pledge Times

Scientists from China have proposed treating severe coronavirus pneumonia using cellular technologies. They plan to use exosomes stem cell secretion products as an active component. Experimental studies have shown that their use significantly reduces pneumonia. This technique is safer than injecting the stem cells themselves into the patient, since there is no risk of mutations and cancer development. Another advantage of such therapy is the ability to store drugs for several weeks or even months, which ensures their safe transportation and delayed use. Russian experts believe that the technique looks promising.

Despite the fact that effective methods of treating patients with severe coronavirus infection have already been worked out, many people, especially the elderly and those with poor health, are still at high risk of dying from pneumonia. Therefore, it is imperative to find a safe and effective therapeutic approach for patients with COVID-19 complicated by acute respiratory distress. In this regard, many research teams are turning their attention to the prospect of using human stem cells.

Scientists at the Shanghai Public Health Clinical Center and Jinyintan Hospital in Wuhan plan to launch a pilot study inhalations with stem cell waste products. We are talking about exosomes bubble-like small particles that release all types of cells into the surrounding fluids. They are needed for the intercellular transfer of various proteins or microRNAs. Such exosomes are also secreted by mesenchymal stem cells, which are proposed to be used in the treatment of severe coronavirus pneumonia.

Photo: REUTERS / Richard Chung

Experimental studies have shown that their use significantly reduces lung inflammation and pathological disorders resulting from various types of lung damage, said in the text of the description of the clinical study. At the same time, scientists note that the intravenous administration of living stem cells (not exosomes), which is also now being studied by various scientific teams, can carry the risks of mutations and the development of cancer. What is not observed in the treatment of cells sprayed in an aerosol.

Another advantage of the proposed technique is the possibility of storing such drugs for several weeks and months, which ensures their safe transportation and delayed therapeutic use. As stated in the document, it is planned to recruit 30 participants for the first stage. It is assumed that each will undergo five inhalation procedures.

Mesenchymal stem cells (MSCs) interact with the innate immune system and can have both anti-inflammatory and pro-inflammatory activity. The type of activity is determined by the source of MSC production, surface markers, the profile of secreted cytokines (proteins secreted by immune cells. Izvestia) and other factors, the acting newspaper told the newspaper. Andrei Vasin, director of the Institute of Biomedical Systems and Biotechnology, Peter the Great St. Petersburg Polytechnic University (the university is a participant of the 5-100 education competitiveness project).

Since the acute respiratory distress syndrome (ARDS) in COVID-19 is believed to be the result of an imbalance of cytokines and other molecules involved in inflammatory responses, it seems reasonable to use approaches to mitigate these responses. A number of studies have been carried out, which suggested the effectiveness of MSCs for the treatment of ARDS, explained Andrei Vasin. Since some of the functions are realized due to the molecules secreted by these cells, it was proposed to use not them, but exosomes containing these molecules.

Scientists have shown that in some cases the use of exosomes gave the same results as the use of MSCs. Therefore, the stem cells themselves do not need to be injected into the patient. This is the approach that the Chinese researchers decided to use in this clinical study, noted Andrey Vasin. And the very possibility of aerosol administration of the drug potentially has a number of advantages from the point of view of the safety profile and the direction of delivery to the pathology site.

Photo: TASS / Zuma / Xinhua

In general, since the beginning of this year, about two dozen studies have been organized around the world using cellular products, Alexey Lyundup, Executive Director of the Association of BMCP (Biomedical Cell Products) Manufacturers, told Izvestia. Moreover, the sources of cells can be different.

The method proposed by Chinese experts is supposed to use exosomes of adipose tissue MSCs, the expert emphasized. Research continues, the idea itself is promising.

According to the specialist, such exosomes from MSCs contain cytokines and growth factors (natural compounds that can stimulate the production of living cells), signal lipids (substances that transmit signals inside the cell) and other substances necessary to relieve inflammation. However, it is worth waiting for evidence of the safety and effectiveness of their use in preclinical studies. And only then begin clinical trials declared by Chinese scientists.

We have sufficient grounds to believe that mesenchymal stem cells (as well as exosomes with similar properties. Izvestia) extinguish the cytokine storm, said Stanislav Otstavnov, deputy head of the laboratory for analysis of population health indicators and digitalization of healthcare at MIPT. I assess the proposed methodology in China as promising, but clinical trials will tell about the effectiveness and safety. In theory, cell therapy should also help in the regeneration of damaged lung areas, but there is little specific information in official sources on this matter. But the decrease in the immune response has been confirmed.

The experts emphasize that, in general, the available data on the use of exosomes in patients with COVID-19 looks interesting and this approach may be promising. However, so far unanswered questions remain related to the dose of such drugs, the route and frequency of administration, recipient groups, interaction with other treatment methods, and so on. Therefore, research in this direction must be continued.

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Breath to the rescue: COVID-19 is offered to be treated with cellular inhalation - Pledge Times

bluebird bio Presents New Results from Clinical Development Program of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral…

Details Category: DNA RNA and Cells Published on Sunday, 30 August 2020 13:01 Hits: 463

Long-term results from Phase 2/3 Starbeam study (ALD-102/LTF-304) suggest durability of response post eli-cel with all 20 patients who were free of major functional disabilities (MFDs) at two years (out of 23 evaluable patients) remaining MFD-free through last available follow-up, including all 10 patients who reached at least Year 5 follow-up visit

31 out of 32 patients in ALD-102 had stable Neurologic Function Scores following treatment with eli-cel, including 24 patients with a score of zero as of the last available visit

In clinical studies of eli-cel to date, there have been no reports of graft failure, graft rejection, graft-versus-host disease (GVHD), replication competent lentivirus, or insertional oncogenesis

Company on track to submit Marketing Authorization Application in EU by year-end 2020, and Biologics License Application in U.S. in mid-2021

CAMBRIDGE, MA, USA I August 29, 2020 I bluebird bio, Inc. (Nasdaq: BLUE) announced updated results from the clinical development program for its investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study (ALD-102/LTF-304) and data from the Phase 3 ALD-104 study. These data were presented today at the 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT 2020), taking place virtually from August 29 - September 1, 2020.

CALD is a fatal neurodegenerative disease primarily affecting young boys. Currently, the only treatment available is allogeneic hematopoietic stem cell transplantation (allo-HSCT), which comes with associated, significant risks, including transplant-related mortality, graft failure or rejection, and graft-versus-host disease (GVHD), said David Davidson, M.D., chief medical officer, bluebird bio. Eighty-seven percent of patients in our Phase 2/3 Starbeam study of eli-cel are alive and free of major functional disabilities (MFDs) at 24 months or more of follow-up. Importantly, there were no reports of graft failure, graft rejection, or GVHD. It is gratifying to see the consistent outcomes with eli-cel and the durability of the treatment effect demonstrated in the children participating in our long-term follow-up study including 10 boys who have now reached at least their Year 5 follow-up visit.

Adrenoleukodystrophy (ALD) is a rare, X-linked metabolic disorder that is estimated to affect one in 21,000 male newborns worldwide. ALD is caused by mutations in the ABCD1 gene that affect the production of adrenoleukodystrophy protein (ALDP) and subsequently cause toxic accumulation of very long-chain fatty acids (VLCFAs) primarily in the adrenal cortex and white matter of the brain and spinal cord.

Approximately 40% of boys with adrenoleukodystrophy will develop CALD, the most severe form of ALD. CALD is a progressive neurodegenerative disease that involves breakdown of myelin, the protective sheath of the nerve cells in the brain that are responsible for thinking and muscle control. Symptoms of CALD usually occur in early childhood and progress rapidly, if untreated, leading to severe loss of neurologic function, and eventual death, in most patients. CALD is associated with six MFDs, which severely compromise a patients ability to function independently: loss of communication, cortical blindness, need for tube feeding, total incontinence, wheelchair dependence, and complete loss of voluntary movement. Nearly half of boys with CALD who do not receive treatment will die within five years of symptom onset.

Patients with CALD experience a rapid decrease in neurologic function after the initial onset of clinical symptoms, so early diagnosis and treatment is critical in order to stop the disease progression and preserve their neurological function. In the Phase 2/3 Starbeam study, 31 of 32 patients had a stable neurologic function score, suggesting that disease progression had stabilized and minimal neurological function was lost, following eli-cel infusion, said Dr. Jrn-Sven Khl, Department of Pediatric Oncology, Hematology and Hemostaseology, Center for Women's and Children's Medicine, University Hospital Leipzig. These results presented at EBMT 2020 are very encouraging and suggest treatment with eli-cel may prevent neurological decline in boys with CALD.

Eli-cel is a one-time investigational gene therapy designed to address the underlying genetic cause of CALD by adding functional copies of the ABCD1 gene into a patients own hematopoietic (blood) stem cells (HSCs) that have been transduced ex vivo with the Lenti-D lentiviral vector (LVV). The addition of a functional gene allows patients to produce the ALDP, which is thought to break down the toxic accumulation of VLCFAs in the brain. There is no need for donor HSCs from another person, as is required for allo-HSCT.

Starbeam Study (ALD-102)/Long-Term Follow-Up Study (LTF-304)

The ALD-102 study has completed enrollment. All reported data below are as of January 2020 and reflect a total population of 32 patients with a median follow-up time of 30.0 months (9.1 70.7 months).

Of the 32 patients who have received eli-cel as of January 2020, 20 have completed ALD-102 and enrolled in a long-term follow-up study (LTF-304). Nine additional patients continue to be followed in ALD-102 and have not reached 24 months post-treatment. As previously reported, two patients withdrew from the study at investigator discretion, and one experienced rapid disease progression early on-study resulting in MFDs and death. To date, 104.3 patient-years of follow-up have been reported for ALD-102 and LTF-304.

The primary efficacy endpoint in the study is the proportion of patients who are alive and free of MFDs at Month 24. Of those patients who have or would have reached Month 24, 87% have met the primary endpoint and continue to be alive and MFD-free at more than two years of follow-up (N=20/23). Fourteen patients have at least four years of follow-up, including 10 patients who have reached at least their Year 5 follow-up visit. The nine patients from ALD-102 that have not reached Month 24 have shown no evidence of MFDs.

Data on several secondary and exploratory efficacy outcomes are reported, including changes in neurologic function score (NFS), a 25-point score used to evaluate the severity of gross neurologic dysfunction across 15 symptoms in six categories; resolution of gadolinium enhancement (GdE), an indicator of active inflammation in the brain; and change in Loes score, an MRI measurement of white matter changes in CALD. Of the 32 patients treated, 31 had stable NFS following treatment with eli-cel, defined as NFS <4, without a change of >3 from baseline, and 24 patients maintained an NFS of 0. An NFS of 0 indicates that there are no concerns with the neurologic functions that are assessed on the 25-point scale. Loes scores generally stabilized within 12-24 months and GdE was no longer seen in most patients following eli-cel treatment.

The primary safety endpoint is the proportion of patients who experience acute (Grade 2) or chronic GvHD by Month 24. GvHD is a condition that may occur after an allo-HSCT, where the donated cells view the recipients body as foreign and attack the body. No events of acute or chronic GvHD have been reported post-eli-cel treatment. There have been no reports of graft failure or graft rejection.

In addition, there have been no cases of replication competent lentivirus or insertional oncogenesis to date. Integration site analysis (ISA) was conducted to determine the pattern of integration post-eli-cel infusion and assess whether dominant or expanding clones were present. In one patient, now enrolled in LTF-304 for long-term follow up, a case of benign clonal expansion was observed with three separate integrations in the DNA of the cell at ACER3, RFX3, and MECOM. As of the patients Month 62 visit in March 2020, the patient remained clinically stable. Bone marrow analyses showed no dysplasia (abnormal cell growth) or molecular abnormalities.

The treatment regimen, comprising mobilization/apheresis, conditioning, and eli-cel infusion, had a safety and tolerability profile primarily reflective of the known effects of mobilization/apheresis and conditioning. In ALD-102, as previously reported, three adverse events (AE) were considered possibly related to drug product and include one serious AE (SAE), BK viral cystitis (N=1, SAE, Grade 3), and two non-serious AEs, vomiting (N=2, Grade 1). All three AEs resolved using standard measures.

ALD-104 Study

bluebird bio is currently enrolling patients for ALD-104, a Phase 3 study designed to assess the efficacy and safety of eli-cel in patients with CALD after myeloablative conditioning using busulfan and fludarabine, a different chemotherapy conditioning regimen than what is used in ALD-102 (busulfan and cyclophosphamide). The primary efficacy endpoint is the proportion of patients who are alive and free of MFDs at Month 24, and the primary safety endpoint is the proportion of patients with neutrophil engraftment after eli-cel infusion. All reported data below are as of February 2020.

In ALD-104, the 13 patients currently on study have a median of 6.1 months of follow-up to date (min-max: 2.2 10.3 months). All 13 patients achieved neutrophil engraftment and 12/13 evaluable patients had platelet engraftment (platelet engraftment pending in one patient as of data cut date). Due to the limited duration of follow-up, only safety data are being presented.

No events of acute or chronic GvHD have been reported and there have been no reports of graft failure, graft rejection, cases of insertional oncogenesis, or replication competent lentivirus.

The treatment regimen, comprising mobilization/apheresis, conditioning, and eli-cel infusion had a safety and tolerability profile primarily reflective of the known effects of mobilization/apheresis and conditioning. In ALD-104, two AEs of pancytopenia were considered possibly related to eli-cel. These two ongoing AEs were deemed as suspected unexpected serious adverse reactions (SUSARs) by the principal investigator and were diagnosed approximately two months post-eli-cel infusion in two patients (one Grade 2 and one Grade 3). An additional AE was ongoing as of February 2020, a Grade 3 SAE of transverse myelitis that was diagnosed in the presence of viral infection (adenovirus and rhinovirus/enterovirus positivity) approximately six months after eli-cel infusion and deemed unrelated to eli-cel.

eli-cel Presentation at EBMT

Lenti-D hematopoietic stem cell gene therapy stabilizes neurologic function in boys with cerebral adrenoleukodystrophy

Presenting Author: Dr. Jrn-Sven Khl, Department of Pediatric Oncology, Hematology and Hemostaseology, Center for Women's and Children's Medicine, University Hospital Leipzig Poster Session & Number: Gene Therapy; ePoster O077

Presentations will be available for virtual viewing throughout the duration of the live meeting on the EBMT 2020 website and content will be accessible online following the close of the meeting until November 1, 2020.

About elivaldogene autotemcel (eli-cel, formerly Lenti-D)

In July 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted an accelerated assessment to eli-cel gene therapy for cerebral adrenoleukodystrophy (CALD). bluebird bio is currently on track to submit the Marketing Authorization Application (MAA) in the EU for eli-cel for CALD by year-end 2020, and the Biologics License Application (BLA) in the U.S. in mid-2021.

bluebird bio is currently enrolling patients for a Phase 3 study (ALD-104) designed to assess the efficacy and safety of eli-cel after myeloablative conditioning using busulfan and fludarabine in patients with CALD. Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information and a list of study sites.

Additionally, bluebird bio is conducting a long-term safety and efficacy follow-up study (LTF-304) for patients who have been treated with eli-cel for CALD and completed two years of follow-up in bluebird bio-sponsored studies.

The Phase 2/3 Starbeam study (ALD-102) has completed enrollment.

For more information about bluebird bio-sponsored studies visit: http://www.bluebirdbio.com/our-science/clinical-trialsor clinicaltrials.gov.

The European Medicines Agency (EMA) accepted eli-cel gene therapy for the treatment of CALD into its Priorities Medicines scheme (PRIME) in July 2018, and previously granted Orphan Medicinal Product designation to eli-cel.

The U.S. Food and Drug Administration (FDA) granted eli-cel Orphan Drug status, Rare Pediatric Disease designation, and Breakthrough Therapy designation for the treatment of CALD.

Eli-cel is not approved for any indication in any geography.

About CALD Early Diagnosis

Early diagnosis of CALD is important, as the outcome of available treatment varies with the clinical stage of the disease. Newborn screening for ALD is a critical enabler of early diagnosis and thus of successful treatment of ALD. Once a patient has been diagnosed with ALD, regular MRI scans are critical to detect white matter changes indicative of progression to CALD.

In the U.S., newborn screening for ALD was added to the Recommended Universal Screening Panel in February 2016 and is currently active in 17 states, accounting for > 58 percent of U.S. newborns. Outside the U.S., the Minister of Health in the Netherlands has approved the addition of ALD to their newborn screening program. Even though ALD newborn screening has not been implemented in most EU countries, efforts to begin pilot programs are slowly progressing.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

SOURCE: bluebird bio

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bluebird bio Presents New Results from Clinical Development Program of elivaldogene autotemcel (eli-cel, Lenti-D) Gene Therapy for Cerebral...

CStone Receives US FDA IND Clearance for CS1001-201 Study to Evaluate Anti-PD-L1 Monoclonal Antibody Sugemalimab Monotherapy in R/R ENKTL – PRNewswire

SUZHOU, China, Aug. 30, 2020 /PRNewswire/ -- CStone Pharmaceuticals (SUZHOU) Co., Ltd. ("CStone", HKEX: 2616) today announced that the US Food and Drug Administration (FDA) has completed their review of the Investigational New Drug (IND) application for anti-PD-L1 monoclonal antibody sugemalimab (CS1001) monotherapy in the relapsed or refractory extranodal natural killer (NK)/T-cell lymphoma (R/R ENKTL) with study may proceed (SMP) letter received.

Sugemalimab is an investigational fully human, full-length anti-PD-L1 monoclonal antibody developed by CStone. Compared with other drugs of the same class, sugemalimab has a lower risk of immunogenicity and potential toxicities in patients. CS1001-201 is a single-arm, multicenter pivotal Phase II clinical study designed to evaluate sugemalimab monotherapy in R/R ENKTL. The IND clearance indicates that the ongoing CS1001-201 study in China will be extended to the US.

ENKTL is a subtype of mature T cell and NK cell lymphoma. Epidemiology of the disease is characterized by higher incidence rates in Asia than in Europe or North America. In China, ENKTL accounts for approximately 6% of all lymphoma cases[1]. R/R ENKTL is highly malignant and aggressive, and has a poor prognosis. Patients with R/R ENKTL lack effective salvage treatments if standard L-asparaginase-based regimens fail, and do not respond well to traditional treatments. For these patients, clinicians almost run out of treatment choices because the disease progresses rapidly with an extremely short overall survival (OS) as indicated by historically reported 1-year OS rate <20%[2]. The currently approved targeted monotherapy in China has a complete response (CR) rate of approximately 6%[3],[4]. There are vast unmet medical needs in this patient population of which the first-line treatment has failed. Sugemalimab is expected to provide new treatment options for these patients.

Dr. Jason Yang, Chief Medical Officer of CStone, commented: "For the treatment of ENKTL, CR rate is a critical outcome measure. Data reported for CS1001-201 study on 2019 ASH meeting shows that sugemalimab demonstrated a CR rate of 33.3% with a durable response, an objective response rate (ORR) of 43.3%, and 1-year OS rate of 72.4%. These results represent a major breakthrough compared to current treatment options and support sugemalimab as a potential conditioning regimen for hematopoietic stem cell transplantation. We will work closely with the US FDA and the National Medical Products Administration (NMPA), to bring sugemalimab to R/R ENKTL patients worldwide soon."

Overview of the CS1001-201 trial

CS1001-201 is a single-arm, multicenter Phase II clinical study designed to evaluate sugemalimab monotherapy in R/R ENKTL. The primary endpoint of the trial is ORR assessed by an independent radiological review committee.

According to updated results reported at the 2019 American Society of Hematology (ASH) Annual Meeting, as of October 8, 2019, a total of 32 patients with R/R ENKTL were enrolled in the study. All patients received sugemalimab 1200 mg intravenously every 3 weeks until disease progression or intolerable toxicity. The median duration of follow-up was 6.54 months (range, 0.7215.64).

Preliminary efficacy data

Sugemalimab demonstrated robust efficacy with a high CR rate and durable response in R/R ENKTL patients:

Safety data

Sugemalimab was well tolerated in patients with R/R ENKTL:

About Sugemalimab

Sugemalimab is an investigational anti-PD-L1 monoclonal antibody discovered by CStone. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.

Sugemalimab has completed a Phase I dose-escalation study in China. During Phase 1a and 1b stages of the study, sugemalimab showed good antitumor activity and good tolerability in multiple tumor types.

Currently, sugemalimab is being investigated in a number of ongoing clinical trials. In addition to a Phase I bridging study in the U.S., the clinical program in China includes one multi-arm Phase Ib study for several tumor types, one Phase II registrational study for lymphoma, and four Phase III registrational studies, respectively, for stage III/IV NSCLC, gastric cancer, and esophageal cancer.

About CStone

CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, 5 late-stage candidates are at pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.

Forward-looking Statement

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

[1], , , , . 10002. . 2012;11(2):111-115.

[2] Bellei M, et al., The outcome of peripheral T-cell lymphoma patients failing first-line therapy: a report from the prospective, International T-Cell Project. Haematologica. 2018;103(7):1191-1197.

[3] Shi Y, Dong M, Hong X, et al. Results from a multicenter, open-label, pivotal phase II study of chidamide in relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015;26(8):1766-1771.

[4] Shi Y, Jia B, Xu W, et al. Chidamide in relapsed or refractory peripheral T cell lymphoma: a multicenter real-world study in China. J Hematol Oncol. 2017;10(1):69.

SOURCE CStone Pharmaceuticals

http://www.cstonepharma.com

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CStone Receives US FDA IND Clearance for CS1001-201 Study to Evaluate Anti-PD-L1 Monoclonal Antibody Sugemalimab Monotherapy in R/R ENKTL - PRNewswire

Stem Cell Therapy Market Size, Overview, Key Players, Regional Demand, Trends and Forecast to 2027 – Scientect

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Platelet Rich Plasma & Stem Cell Alopecia Treatment Market 2020 to Witness Lucrative Growth in Coming Years – Scientect

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Platelet Rich Plasma & Stem Cell Alopecia Treatment Market 2020 to Witness Lucrative Growth in Coming Years - Scientect

Global Stem Cell Cartilage Regeneration Market Analysis, Drivers, Restraints, Opportunities, Threats, Trends, Applications, And Growth Forecast To…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Stem Cell Cartilage Regeneration Market market.

Trusted Business Insights presents an updated and Latest Study on Stem Cell Cartilage Regeneration Market Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Stem Cell Cartilage Regeneration Market market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Global Stem Cell Cartilage Regeneration Market 2020 (Includes Business Impact of COVID-19)

Global Stem Cell Cartilage Regeneration Market Analysis Trends, Applications, Analysis, Growth, and Forecast to 2028 is a recent report generated by Trusted Business Insights. The global stem cell cartilage regeneration market report has been segmented on the basis of stem cell type, treatment, end user, and region.

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Global Stem Cell Cartilage Regeneration Market: Overview

Stem cell-based therapy is important factor in functional replacement of cartilage regeneration. Stem cells are categorized into three kind of cells namely: hematopoietic stem cell, mesenchymal stem cells, and pluripotent stem cells.

Global Stem Cell Cartilage Regeneration Market: Dynamics

Rising adoption of minimally invasive surgery procedures, owing to its benefits such as lower risk and shorter duration for surgery is a key factor expected to drive growth of stem cell cartilage regeneration market over the forecast period.

In addition, increasing incidence of osteoarthritis among population across the globe, which in turn expected to support rising adoption of stem cell cartilage regeneration therapy. This factor is expected to boost growth of the target market over the forecast period.

Moreover, government initiatives such as government agencies which focusing on some policies in order to increase adoption of stem cell therapies is another factor expected to propel growth of target market over the forecast period.

However, higher treatment cost is a key factor expected to restrain growth of the global stem cell cartilage regeneration market over the forecast period. In addition, lack of skilled professionals to access stem cell sourcing, processing, or delivering these technologies is another factor expected to hamper growth of the target market over the forecast period.

Ongoing trend observed in the target market is increasing prevalence of osteoarthritis among population and rising adoption of minimally invasive surgery procedures which is turn expected to support growth of the global stem cell based cartilage regeneration market over the forecast period.

Increasing development of innovative technologies, products, and research and development (R&D) activities by key players are major factors expected to create potential revenue opportunities for the target market over the forecast period. In addition, increasing strategic partnership, merger, and acquisition activities by manufacturers are some other factors expected to create lucrative opportunities for player operating in the global market.

Global Stem Cell Cartilage Regeneration Market: Segment Analysis

Among the stem cell type segments, the mesenchymal stem cells segment is expected to register highest CAGR in the target market, owing to increasing research and development activities by various research organizations across the globe.

Global Stem Cell Cartilage Regeneration Market: Regional Analysis

The market in North America is expected to dominate in the global stem cell cartilage regeneration market in terms of revenue over the forecast period, owing to presence of key players operating in the target market such as Vericel Corporation, Osiris Therapeutics, among others and innovative stem cell based cartilage regeneration product launches, and development of new technologies across various countries in the region. In addition, rising geriatric population, which is more prone to degenerative disorders such as osteoarthritis across US is another factor expected to boost growth of the target market in this region.

The market in Asia Pacific is expected to register significant growth in terms of revenue over the forecast period, owing to stem cell based cartilage regeneration procedures are conducted by various hospital, specialty care, and clinics across India.

Global Stem Cell Cartilage Regeneration Market Segmentation:

Segmentation by stem cell type:

Hematopoietic Stem Cells (HSCs) Pluripotent Stem Cells (iPSC/ESCs) Mesenchymal Stem Cells (MSCs)

Segmentation by treatment:

Microfracture Osteochondral Transplant Autologous Chondrocyte Implantation Stem Cell Injections

Segmentation by end user:

Hospitals & Clinics Ambulatory Surgical Centers

Looking for more? Check out our repository for all available reports on Stem Cell Cartilage Regeneration Market in related sectors.

Quick Read Table of Contents of this Report @ Global Stem Cell Cartilage Regeneration Market 2020 (Includes Business Impact of COVID-19)

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Global Stem Cell Cartilage Regeneration Market Analysis, Drivers, Restraints, Opportunities, Threats, Trends, Applications, And Growth Forecast To...

Mesoblast revenue jumps ahead of critical month – Sydney Morning Herald

Stem cell treatments business Mesoblast has managed to boost revenues more than 90 per cent over the past year, with the company looking towards September as a critical month of news that will determine the future of its flagship products.

Chief executive Dr Silviu Itescu said the company was eyeing long-term applications for its treatments including possibly targeting 200,000 patients in the US experiencing respiratory distress each year. The company is investigating the use of its products for COVID-19 patients with the belief the impacts of coronavirus on global healthcare systems will be felt for the long term.

"The next few months are certainly going to be transformational for the company": Dr Silviu Itescu, chief executive of stem cell company Mesoblast.Credit:Josh Robenstone

"I think everyone is seeing it that way that COVID will always be there with us. It's [about] how much we are in control of it," he said.

The $3 billion biotech revealed revenues of $US32.2 million ($44.5 million) for 2020, a 92 per cent improvement on 2019's numbers. This was largely driven by royalty and milestone payments to the company from its strategic partnerships with other biotechs.

The business managed to trim its losses 13 per cent, though is still operating at a net loss of $US77.9 million. Mesoblast spent $US56 million on research and development, which was a $US8.6 million reduction on the previous year.

Mesoblast shares gained 2.3 per cent to sit at $5.30 at midday.

Mesoblast's flagship product is remestemcel-L, which it hopes to soon launch into the US market for treatment of acute graft-versus-host disease in children. Earlier this month it secured a major win when an FDA advisory committee voted in favour of the treatment, branded as Ryoncil, as effective in treating the disease.

Chief executive Dr Silviu Itescu said the FDA has set an action date of September 30 to make a final call on the product and if approved the business has put manufacturing in place to launch almost immediately.

"The next few months are certainly going to be transformational for the company," Dr Itescu said on a call to analysts on Thursday morning.

The company is also trialling the same product for treatment of acute respiratory distress for COVID-19 and is currently running a phase 3 trial in the United States.

Dr Itescu said the launch of a COVID-19 treatment was a key focus moving forward, with initial read-outs of the phase 3 data expected to begin in the first weeks of September.

"Its a very important focus for the company, as it should be throughout this dreadful pandemic," he said.

Mesoblast has spent a significant amount of 2020 working on scaling up manufacturing capabilities in preparation for these two projects being approved. It has inked a commercial supply agreement with multinational biotech Lonza and is looking to scale this up.

The company has seen volatile share price movements in recent weeks after the company has given updates, including losing 30 per cent in a single session earlier this month. Long-time backer Thorney Investment Groups chairman Alex Waislitz has said the company requires a long term view.

"Theyre dealing with very big markets if they can get those approvals," he said.

Last week Bell Potter lifted its target price for the stock to $7.30, with analysts saying they expect the company's Ryoncil product will get final approval for use in graft-versus-host disease.

There are still a number of hurdles ahead before the COVID-19 treatment could be approved, however Mesoblast's phase 3 study is set to cover 300 patients and recruitment is not expected to complete until the fourth quarter of this calendar year.

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Emma reports on healthcare companies for The Age and Sydney Morning Herald. She is based in Melbourne.

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Mesoblast revenue jumps ahead of critical month - Sydney Morning Herald