Author Archives: admin


Symposium discusses latest and future of stem cell therapy – The Pasadena Star-News

DUARTE>> Dozens of doctors, scientists, businesses and others gathered at City of Hope Thursday for the second California Institute for Regenerative Medicine (CIRM), Alpha Stem Cell Clinics symposium.

CIRM, the states stem cell agency, has developed a network of Alpha Stem Cell Clinics that focus on innovative stem cell-based therapies. The network of three clinics are located at City of Hope, University of California, San Diego, and UCLA/UC Irvine campuses.

The event served as a way for clinics to share their most recent advancements and successes in stem cell therapy clinical trials, and even hear directly from patients who benefited from some of the trials.

We want to review the trials, but we also want to see what other questions we should be asking, said Dr. John Zaia, the Aaron Miller and Edith Miller Chair in Gene Therapy, and director of the Center for Gene Therapy and principal investigator of City of Hopes Alpha Stem Cell Clinic. How will insurance companies charge or pay for these treatments? How do companies plan to develop these treatments? The symposium provides an opportunity to think about these other aspects.

There were also panel speakers who offered more of a motivational talk, such as Pat Furlong, founding president of Parent Project Muscular Dystrophy, discussing how to remove stakeholder barriers to stem cell therapy treatment.

Furlong had to become her and her sons own advocate when they were diagnosed with Duchenne Muscular Dystrophy at a young age. She found there was no standard of care for the disease and no studies or trials in progress to find a treatment, let alone a cure.

Families just didnt know the questions to ask, she said. At the time, few people cared about rare diseases.

After years of no real hope and losing her sons at 15 and 17 years old, with her and her groups persistence, Furlong said there are now 40 companies researching the disease and millions of dollars have gone into research specifically for Duchenne.

City of Hopes Dr. Behnam Badie, chief of neurosurgery and director of the Brain Tumor Program, and Christine Brown, Ph.D., Heritage Provider Network Professor in Immunotherapy and associate director of the T Cell Therapeutics Research Laboratory, discussed their recent successful treatment of a patient with recurrent multifocal glioblastoma using CAR-T cell therapy.

The case study for this unique type of immunotherapy on the most aggressive form of brain cancer was published in the Dec. 29 edition of the New England Journal of Medicine.

Advertisement

In the Phase I clinical trial, the patient, who did not respond to other types of therapy including radiation and even developed tumors in his brain and spinal cord, was treated with his own genetically modified chimeric antigen receptor (CAR) T cells, injected directly into the tumor and through the ventricular system. The patient experienced remission over 8 months.

City of Hope is one of a few cancer centers in the nation offering studies in CAR-T cell therapy, and is the only cancer center investigating CAR-T cells targeting the specific receptors more common in a majority of glioblastomas.

Dr. Badie and Brown noted that working with CIRM has been instrumental in helping them along with their trial, and not just the funding.

You cant create a good trial without studying the product, said Brown. These are expensive trials. We have to treat these patients and understand what is going on.

Go here to read the rest:
Symposium discusses latest and future of stem cell therapy - The Pasadena Star-News

Erectile dysfunction: Stem cell therapy restores sexual function in phase I trial – Medical News Today

Early results of a clinical trial suggest that stem cell therapy may be a promising treatment for erectile dysfunction, after the procedure was found to restore sexual function in men with the condition.

The stem cell therapy involves injecting the patients' own stem cells - derived from abdominal fat cells - into the erectile tissue of the penis.

Lead researcher Dr. Martha Haahr, of Odense University Hospital in Denmark, and colleagues found that within 6 months of the procedure, 8 of the 21 men treated were able to engage in spontaneous sexual intercourse.

The researchers recently presented their findings at EAU17 - the European Association of Urology's annual conference - held in London in the United Kingdom.

Erectile dysfunction (ED) is a condition whereby a man has difficulties getting or maintaining an erection in order to engage in sexual intercourse.

According to the National Institute of Diabetes and Digestive Kidney Diseases, around 12 percent of men under the age of 60, and 22 percent of men aged between 60 and 69, have ED.

High blood pressure, diabetes, heart disease, chronic kidney disease, and prostate surgery are some of the physical conditions that can cause ED. Psychological issues - such as anxiety, stress, depression, and low self-esteem - can also contribute to ED.

Current treatments for ED include PDE5 inhibitors (such as Viagra), penile implants, and injections. However, Dr. Haahr and team note that all of these therapies can have significant side effects.

As a result, researchers are on the hunt for alternative treatments for ED, and stem cell therapy has emerged as a promising candidate in animal trials.

In their phase I trial, Dr. Haahr and colleagues tested stem cell therapy on 21 men who had ED as a result of undergoing radical prostatectomy for prostate cancer. None of the men had responded to standard medical treatment for ED.

For the stem cell procedure, abdominal fat cells were extracted from each man through liposuction. Stem cells were then isolated from the fat cells and injected into the corpus cavernosum of the penis - the spongy tissue that normally becomes filled with blood during an erection.

Before the stem cell procedure and 6 and 12 months after, the participants' erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire. An IIEF score of 5-7 represents severe erectile dysfunction, 12-16 is mild to moderate erectile dysfunction, and 22-25 is no erectile dysfunction.

All 21 men saw their erectile function improve with stem cell therapy: their IIEF score increased from 6 prior to treatment to 12 at 6 months after treatment.

Eight of the men reported that they had been able to engage in spontaneous sexual activity 6 months after stem cell therapy, and this outcome remained evident at 12 months after treatment. These men saw their IIEF score rise from 7 to 14 with stem cell therapy.

"What we have done establishes that this technique can lead to men recovering a spontaneous erection - in other words, without the use of other medicines, injections, or implants," says Dr. Haahr.

Although the study findings are preliminary, the team says that they show promise for stem cell therapy as an effective treatment strategy for ED.

"We are the first to use a man's own fat stem cells as a treatment for erectile dysfunction in a clinical trial. The technique has been trialed in animal work, but this is the first time stem cell therapy has allowed patients to recover sufficient erectile function to enable intercourse," says Dr. Haahr.

"We are pleased with the preliminary outcomes, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 12 months follow-up, indicating that this might be a long-term solution.

This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. But we need to remember that this is a small trial, with no control group. We're still some time away from a clinically available solution."

Dr. Martha Haahr

The researchers are now in the process of initiating a phase II trial to further investigate the safety and efficacy of stem cell therapy for ED.

Learn how eating more fruits could help to lower the risk of ED.

Originally posted here:
Erectile dysfunction: Stem cell therapy restores sexual function in phase I trial - Medical News Today

Man with 45% burns healed with stem cell treatment – ETHealthworld.com

Mumbai: A 45-year-old man -- suffering from 45 per cent burns due to a chemical spill at work -- has been healed with stem cell treatment, said the authorities at a hospital here on Friday.

Ram Naik (name changed) was brought to city-based StemRx Bioscience hospital after receiving first aid in another hospital. Nearly 45 per cent of his upper body was burned due to a chemical spill during work.

The impact of the burns led to a charred look on his face and body. Also, joint mobility due to the burns was reduced. The outer layer of the skin was affected, facial burns were of grade II level and in some instances grade III burns were also present, leading to deeper structures like the subcutaneous tissue also being affected.

According to the doctors, burn wound healing involves a series of complex processes, with healing time and scar tissue being the most important parameters that affect treatment outcomes. Burn injuries, especially severe ones, are proving to have devastating effects on the affected patients.

They said that stem cells have been recently applied in burn wounds to promote superior healing of the wounds. Not only have stem cells been shown to promote better and faster healing of the burn wounds, they are also capable of decreasing inflammation and prevent scar progression and fibrosis.

Therefore, the doctors decided to provide Naik stem cell treatment.

Regenerative Medicine researcher at Stemrx Bioscience hospital Pradeep Mahajan said that within two days, a notable improvement in his condition was observed and the swelling and charred appearance started reducing.

"Mild eyelid movements were noticed and on the third day the burns started drying on the face and he could open his mouth and eyes. Growth factors derived from platelets, cells, fibroblasts, collagen-based gel etc. was used during treatment. In addition, in areas with deep burns, sheets of PGLA coated with cells and growth factors were used," said Mahajan, adding that different medication and treatments were imparted and closed dressing was avoided.

"Blood transfusion and supplementary fluids were given intravenously to maintain systemic homeostasis," said Mahajan.

Stating that on 5th and 6th day following treatment, dry scales from the face and body started peeling off, the doctor's team also observed impressive changes such as new skin forming within a week of treatment with cells and growth factors.

By conventional modalities, it takes more than eight weeks for the patient to heal and many additional months for the patient to be able to regain joint and facial movements.

"By the 10th day of the treatment, dry scales completely peeled off and by the 14th day the patient had no tenderness or burning pain. Joint movements became free as well, Steady rate of progression of healthy skin formation is being noticed. Areas with deep burns are also healing at a rapid rate and I am confident that within a month we will accomplish thorough healing and the patient will be back to normal," Mahajan said.

Medical sciences say that such cases are challenging to manage considering the degree of impairment they result in due to prolonged healing period. Also, through conventional therapeutic modalities healing occurs with scar formation and results in contractures. Chances of systemic complications and infection are also high.

However according to the medical team, by using stem cells, the natural healing potential of the body is used, leading to reduction of healing time and promoting regeneration of affected tissues. This also reduces the mental trauma and financial burden that a patient goes through when under conventional management.

"Stem cell-based therapy has offered a novel and powerful strategy in almost every medical specialty including burns and wound management. Stem cells have proven to have tremendous potential in enhancing wound healing and facilitating skin regeneration," Mahajan said.

Go here to read the rest:
Man with 45% burns healed with stem cell treatment - ETHealthworld.com

Inside Green Bay area’s first stem cell clinic – WBAY

HOWARD, Wis. (WBAY) - After two car accidents left her with serious pain in her neck, back, legs and shoulders, Cindy Kastelic says she was starting to lose hope.

"I'd go to the chiropractor, then I'd go in for myofascial release and acupuncture, and sometimes I would go and spend $150, and within an hour it's like I was hurting again, I just wasted all that money."

Three months ago, Kastelic saw an ad for amniotic stem cell treatment and attended a seminar.

She immediately signed up for a treatment to her neck and lower back.

"Amazing that I could move my neck without being in pain, I could sleep on my left or right side without waking up with a kink in my neck, and my lower back started feeling better.," Kastelic said.

"This isn't something that just popped up overnight. This treatment has been going on for years and years and years," Northwoods Family Physical Medical Clinic director Kim Scarlassara said.

Based in Iron River, Mich., Northwoods Family Physical Medicine just opened a clinic in Howard based, it says, on demand from patients suffering from degenerative joint issues.

"Stem cells are the body's master cells," Scarlassara explained. "They have the ability to become basically any other type of cell in your body, like a bone cell, a ligament cell, a cartilage cell. They have the ability to help your body rebuild, repair and regenerate."

Kastelic was back at the clinic Friday for a stem cell treatment to her knees and shoulders.

She calls it a life-changing procedure without the need for surgery or medication.

Diana Hardy of Northwoods Family Physical Medicine said, "I think overall people don't want any more surgeries and that expense and that risk and side effects and medications, pain medications."

Read the original post:
Inside Green Bay area's first stem cell clinic - WBAY

Stem cell treatments can go wrong – Jamaica Observer

Stem cells are the foundation of all our body cells before they differentiate to become specialised cells that grow into our tissues and organs, such as kidney cells, muscle cells, nerve cells, and so on.

They commonly come from two sources: The embryo (embryonic stem cells formed in early development after the human egg is fertilised by a sperm); and adult tissue (adult stem cells, such as those existing in bone marrow to later differentiate to form red blood cells, white blood cells and other components of the blood).

The use of human embryonic stems cells for treatment or research is often frowned upon by some people, as they regard the human embryo as a person that should not be discarded after such endeavours. Consequently, much scientific work has recently been focused on the use of adult stem cells.

THE USE OF STEM CELLS

Stem cells may be beneficial in treating diseases that are amenable to cell replacement. However, this is still a young science, and belief that a particular treatment helps two or three people does not convince the scientific community or the whole society that the treatment will work for everyone so afflicted.

Scientific proof comes from conducting clinical trials, the international gold standard often involving hundreds of people so afflicted and comparing them with an equivalent number of people not afflicted to determine whether a treatment really works for those who receive it.

Whilst many stem cell research projects are currently being conducted in various centres around the world to determine whether they produce benefits, and what may be the possible risks involved, there are also medical clinics that are using stem cells not in a registered research project, but rather in the actual treatment of affected people.

TREATMENT CAN CAUSE HARM

A recent report in the highly respected New England Journal of Medicine informed that three elderly women in Florida had been blinded by an unproven treatment.

They had signed up for a purported clinical trial in 2015 for which they had to pay US$5,000 each. Before surgery, the vision in their eyes varied from 20/30 to 20/200, but within one week after surgery, they experienced a variety of complications, including vision loss, detached retinas and bleeding into their eyes, resulting in total blindness.

The authors of the article from the Standard University School of Medicine sought to make patients, doctors and the various regulatory agencies aware of the risks of such a minimally regulated, patient-funded research. It stated that some clinics appeal to patients that are desperate for care and who hope that stem cells will be their answer, but as in the case of these women, some of these current enterprises are very dangerous.

At this particular clinic, fat cells were taken from the patients abdomens and processed to obtain stem cells which were then injected into their eyes. The patients reported that the entire process took less than one hour. The patients had both eyes treated at once, even though most doctors would opt for a conservative approach to observe how the first eye responds.

THE NEED FOR THE REGULATION OF RESEARCH

The article stated that while there is a lot of well-founded evidence for the positive potential of stem cell treatment for many human diseases, such treatments should be conducted in a well-designed clinical trial based on pre-clinical research.

The treatment done for the women lacked nearly all the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, the involvement of a control group of people and a treatment group, the safe collection of data, the masking of clinical and patient groups, and plans for follow-up.

Clinics offering stem cell treatments exist in Jamaica, The Bahamas and Cuba. However, while both The Bahamas and Cuba have developed regulations that stipulate in law the conditions to be met for stem cell treatments and research within their jurisdictions, Jamaica has developed no such regulation.

THE MEDICAL ACT DOES NOT PROVIDE PROTECTION

The Medical Act of Jamaica was passed in 1976, but does not mention or provide any guidance or protection regarding research with human participants.

Its focus was to: Register medical practitioners; appoint examiners to conduct exams for people applying for registration, and ensure the maintenance of proper professional conduct by practitioners.An amendment in 2004 added the requirement of continuing medical education for practitioners.

Guyana and St Lucia are the only countries in the Caribbean that have joined the progressive countries who all have legislation governing research with human participants within their borders. Regulations should stipulate the requisite conditions, including that treatment and research be monitored by an appropriate ethics committee to meet all international standards.

Without this, vulnerable people seeking health benefits will unknowingly continue to subject themselves to risks of harm without the protection that proper regulations can provide.

Derrick Aarons MD, PhD is a consultant bioethicist/family physician, a specialist in ethical issues in medicine, the life sciences and research, and is the Ethicist at the Caribbean Public Health Agency (CARPHA). (The views expressed here are not written on behalf of CARPHA)

See the rest here:
Stem cell treatments can go wrong - Jamaica Observer

Stem cell agency founder eyes $5 billion in state funding – Capitol Weekly

News

by DAVID JENSEN posted 03.24.2017

The man often called the father of the California stem cell agency all but said he is set to launch an effort to pump an additional $5 billion in state funding into the research effort, which is scheduled to run out of cash in about three years.

Robert Klein, a wealthy real estate investment banker, told a packed audience on Thursday at the City of Hope inthe Los Angeles area that a public opinion poll would be taken next fall in California to gauge support for a new bond measure to support the agency. He said that California has the opportunity and privilege to lift the human condition.

A revolution is underway, Klein said.

The agency has yet to produce a stem cell therapy for widespread public use despite the expectations raised by Kleins campaign 12 years ago.

Klein managed the 2004 campaign that created the stem cell agency, and he oversaw the writing of the 10,000-word initiative that placed the agencys spending outside of the control of the Legislature and governor. Klein spoke at a day-long symposium involving the states soon-to-be $40 million, Alpha stem cell clinic network, which is scheduled to grow from three to five sites later this year.

Researchers, business executives and patients praised the performance of the clinics which were initiated with support from the California Institute for Regenerative Medicine, as the Oakland-based agency is formally known.

Klein, who served as the agencys first chairman until 2011, praised its work. He also noted that California has 50 percent of the nations biotech infrastructure. He said the state has an historic opportunity to carry the current stem cell research forward.

Klein did not say specifically he would organize a new campaign for a bond measure for the agency. But he was more specific about the voter poll this fall and was optimistic about the future of the research in California. He said,:

This fall when the citizens of California are polled, Ibelieve they will say (the agencys) results are encouraging.

The agency has yet to produce a stem cell therapy for widespread public use despite the expectations raised by Kleins campaign 12 years ago.

Klein did not say who would fund the poll or how campaign funds would be raised. However, he has an organization called Americans for Cures, which had its origins in the campaign of 2004. That ballot measure effort cost $34 million.

A new bond measure would likely be mounted in the 2018 November general election, which would improve the likelihood of approval plus help to provide timely financial continuity for the agency. Eds Note:Eds Note: David Jensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report, where this story first appeared. He has published more than 4,000 items on California stem cell matters in the past 11 years.

Support for Capitol Weekly is Provided by:

Read more here:
Stem cell agency founder eyes $5 billion in state funding - Capitol Weekly

Stem cell breakthrough offers hope for men with erectile dysfunction after prostate surgery – The Independent

A breakthrough in stem cell research has given men left with erectile dysfunction after prostate surgery the chance to enjoy normal intercourse again, according to new research.

In early clinical trials, eight out of 15 incontinent men suffering from erectile dysfunction were able to have sex, six months after undergoing a one-time stem cell treatment, Scientists told European Association of Urology's annual meeting in London.

All of the men involved had used pills or devices to get an erection beforehand, leadresearcherDr Lars, Lund toldThe Independent.

Fifty-three per cent of the men have kept the ability [to have sex] after one year, without having to use drugs or implants and other devices," added theprofessor atOdenseUniversity Hospital inDenmark. Its very promising.

Prostate surgery is responsible for up to 13 per cent of erectile dysfunction cases.

Researchersremovedfat cells from a patients abdomen via liposuction. Theyundergo a brief treatment and are turned into all-purpose stem-cells, meaning they are able to mutate into nearly any cell in the body.

Dr Lund said the study is the first of its kind to inject stem cells directly into the penis with a syringe.There,they begin to transform into nerve and muscle cells, as well as endothelial cells that line blood vessels, he said.

Men are put under general anaesthesia while the procedure happens, and are discharged from hospital the same day.

The next step will see his team to perform a randomised controlled trial of the treatment.

Participants will be randomly assigned one of several clinical interventions alongside a control group, in which subjects are given a placebo or no intervention.

Dr Lund said that while the research is still in its early stages, the results so far have already showed promise.

View original post here:
Stem cell breakthrough offers hope for men with erectile dysfunction after prostate surgery - The Independent

New stem cell method produces millions of human brain and muscle cells in days – Science Daily


Science Daily
New stem cell method produces millions of human brain and muscle cells in days
Science Daily
The OPTi-OX method could be used to make many cell types that haven't been possible to grow before. Credit: Matthias Pawlowski et al. Stem Cell Reports (2017) Wellcome Trust Sanger Institute Wellcome Trust - Medical Research Council Cambridge Stem ...
New tools to study the origin of embryonic stem cellsPhys.Org
Cambridge scientists help develop new stem cell method | News ...The Cambridge Student
Scientists Use Stem Cells to Grow Brain and Muscle Cells Faster Than EverInverse
Medgadget (blog) -Wall Street Pit -Nature -University of Bristol
all 37 news articles »

See more here:
New stem cell method produces millions of human brain and muscle cells in days - Science Daily

Failed cell therapy study offers positives, raises new questions – ModernMedicine

Patients with a history of frequent anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of age-related macular degeneration (AMD) may not be the best potential candidates for encapsulated cell technology (ECT).

ECT contains human cell lines that are capable of producing a variety of proteins. After a single surgical implantation, they can produce proteins for up to two years or more, according to Szilard Kiss, MD, assistant professor of ophthalmology; director of clinical research at Weill Cornell Medical College, New York.

These cell lines survive even after being inside the human eye for six months, Dr. Kiss said.

A phase II study was initiated to compare the third generation of ECT (Neurotech, Cumberland, RI) to aflibercept (Eylea, Regeneron Pharmaceuticals). The study planned to enroll 90 subjects, with a primary outcome of non-inferiority to aflibercept alone after 108 weeks. Among the patient entry criteria, all patients had to have shown a response to aflibercept before randomization.

The patient profile was similar to other anti-VEGF treatment studies, with a best corrected visual acuity (BCVA) between 80 letters (20/25) and 35 letters (20/200) at baseline; limited pathology (such as fibrosis, scarring, or atrophy); good optical coherence tomography (OCT) response to injections; and having gone through at least three previous injections, with the last injection no more than four months before study enrollment.

The goal was to have fewer than 20% of patients needing a rescue injection during the follow-up period, Dr. Kiss said.

Study particulars

Unfortunately, there was not a significant difference between the implanted patients and those that received aflibercept. Those subjects that went on to 24 weeks may appear to have gained a little bit of vision, and one subject seemed to benefit, Dr. Kiss said. The OCT results show a saw-toothed pattern that we can see in patients who are treated with aflibercept every 8 weeks.

Although the responses look impressive, most subjects underwent rescue injections of aflibercept, Dr. Kiss said.

The time to rescue injections actually occurred as soon as 4 weeks after the implantation. And as such, there was early termination of the study, because it was not going to meet the primary endpoint of fewer than 20% needing injections, Dr. Kiss said.

However, the implantation itself was deemed successful, as the cells survived and produced the anti-VEGF molecule, but the amount that was produced was significantly below the 12 g/mL necessary.

There were two outlier subjects who had received an aflibercept injection alone about 10 days before the explant, and before measuring anti-VEGF activity. Dr. Kiss believes that to be the cause of the higher numbers compared to other subjects in the study.

None of the explants who did not receive aflibercept right before the explant produced enough anti-VEGF activity, he said.

Positive take-home

However, there had been indications the technology would be successful for this indicationa patient who had undergone six aflibercept injections during the previous year before enrollment did not need any injections (rescue therapy) during the 28 weeks before the AMD study terminated.

On the positive side, Dr. Kiss said the study results created new questions for the technologyincluding whether the approach could achieve better outcomes compared to real-world experience with other patient populations since the cell viability and stability was good.

The third generation ECT (NCT-503-3) did achieve the goal of improved VEGF-receptor production by at least 2-fold compared to double ECT (NT-503-2) implants. Further, while VEGF levels were not detectable, a complex formation was observed in the preliminary native gel.

While the AMD study has been halted, the company is investigating the technology in an ongoing phase II study in conjunction with the MacTel Project to investigate the long-term delivery of ciliary neurotrophic factor (CNTF) in people with macular telangiectasia (MacTel). A pilot study of neuro-enhancement in subjects with early visual impairment in collaboration with clinicians at Stanford University is also under way.

Most promising is that ECT is a unique and versatile drug delivery platform, with more than 1,000 patient years of safety data, Dr. Kiss added. The long-term continuous release of therapeutic proteins via ECT remains a viable and effective way to treat chronic ocular conditions.

Szilard Kiss, MD

E:[emailprotected]

This article is adapted from a presentation that Dr. Kiss presented at the Retina Subspecialty Day, prior to the 2016 American Academy of Ophthalmology meeting.

Continue reading here:
Failed cell therapy study offers positives, raises new questions - ModernMedicine

Caladrius: ‘Hitachi will unlock full potential of cell therapy CDMO PCT’ – BioPharma-Reporter.com

Hitachi Chemical Co. America will increase its presence in the cell therapy development and manufacturing space through the $75m acquisition of Caladrius Biosciences subsidiary PCT.

The US off-shoot of Japanese firm Hitachi Chemical has entered an agreement to up its position in cell therapy contract development and manufacturing organisation (CDMO) PCT by buying out majority shareholder Caladrius Biosciences for a total of $75m in a deal expected to close in May.

Im delighted to report the entry into an agreement for the acquisition of our remaining 80.1% interest in PCT by Hitachi Chemical, Caladrius CEO David Mazzo said on a conference call to discuss his firms Q4 results this week. This transaction has the potential to unlock the tremendous value of our PCT asset in a way that was unimaginable just a few years ago.

He explained Caladrius has been increasingly challenged by the tens of millions of dollars of additional capital investment need over the next several years for PCT to fully realise its cell therapy commercial manufacturing growth goals, and added Hitachi is in a position to deploy the capital and engineering capabilities needed to achieve these.

Caladrius will continue to use PCT for the manufacturing and development of its own cell therapy candidates including CLBS03, a T-regulatory (Treg) cell-based therapy for the treatment of type 1 diabetes mellitus without the burden of having to try to support and grow that business due to the very, very large capital needs necessary to remain competitive, he told stakeholders.

The deal will include the transfer to Hitachi of cGMP-compliant facilities in Allendale, New Jersey and Mountain View, California offering quality systems, streamlined technology transfer, storage and logistics, and cell and tissue processing services.

In a statement following the announced acquisition, PCT said: Our relationship with our clients does not change based on this announcement, nor will it change based on the finalization of this transaction.

Continue reading here:
Caladrius: 'Hitachi will unlock full potential of cell therapy CDMO PCT' - BioPharma-Reporter.com