Category Archives: Cell Therapy

LUCY Clarke was facing a downhill spiral when she flew to Russia to undergo a cutting edge stem cell transplant.

Two years on she says the procedure not only halted her illness in its tracks, but reversed much of the damage inflicted by multiple sclerosis.

The 41-year-old from Inverness is now backing crowdfunding efforts so that her friend and neighbour, Rona Tynan, can receive the same life-changing operation in Mexico before she becomes too ill to qualify.

Mrs Tynan, 50, has until the end of August to raise the 60,000 needed.

However, both are angry at a cross-border divide which means that a small number of MS patients in England can undergo the treatment for free on the NHS, while in Scotland despite having some of the highest rates of MS in the world the health service has refused patients' funding and no clinical trials are planned.

Mrs Clarke, a chemistry graduate and acupuncturist, began investigating AHSCT (autologous haematopoietic stem cell transplantation) in 2014 after her condition progressed from relapsing-remitting to secondary progressive MS. At the time her son was three and she feared ending up in a wheelchair.

Although the treatment has been available overseas for decades, it has never been routinely available on the NHS and is considered unproven by many neurologists.

It is also a highly aggressive therapy, using intensive chemotherapy to strip out sufferers faulty immune systems before replenishing it with stem cells harvested from their own bone marrow or donor tissue. Despite the risks, many patients including Mrs Clarke credit it with transforming their lives.

She underwent the procedure in Moscow over a period of four weeks in April and May 2015. She said: From when my son was three to when I had the transplant, my walking had deteriorated, I needed to use a walking stick all the time, I had very poor balance, debilitating fatigue, I had brain fog, I used to slur my words.

"Im left-handed and my left hand was really weak so my writing was bad. Other things would come and go numbness in my legs, tingling, cramps in my calves, sore and painful legs. The majority of them have gone since the transplant.

I noticed quite quick improvements in things like balance. The biggest thing is not really having fatigue, and the brain fog completely went. I stopped slurring my words quite quickly after treatment. I was more alert. I had more concentration, more focus. Within six months the shaking in my left arm had gone. Ive still got drop foot in my right leg and I still use a walking stick, but once youve got to the stage of secondary progressive it all gets a bit scary. Things are going downhill and youre told theres nothing that can be done, so really my goal from treatment was just to halt the progression to know I wasnt getting any worse. Thankfully, and luckily, I have seen lots of benefits.

Eighteen months on, MRI brain scans show no signs of disease progression and while Mrs Clarke stresses that the treatment is neither a magic bullet nor a walk in the park, she is supporting Rona Tynans bid to undergo the same surgery in October.

Mrs Tynan, a retired Metropolitan police sergeant and mother-of-two from Inverness, also has secondary progressive MS. She is already in a wheelchair and fears that unless she undergoes the treatment soon she will become too ill. She said: Im a 7.5 out of 10 on the disease progression scale, where 10 is death. Most clinics stop taking you at seven, but Mexico just raised it to 8.5. Thats brilliant for people like myself, but I cant afford to get any more ill.

So far, Mrs Tynans fundraising page on JustGiving has raised nearly 4000, but she is frustrated that more is not being done to help Scottish patients. In England, clinical trials are ongoing in London and Sheffield but a small number of patients with relapsing-remitting MS can be referred for the treatment off-trial, for free, on the NHS. In Scotland, however, eligible patients have been turned down for NHS funding.

Mrs Tynan said: It seems crazy to me that Brits are going to Chicago and Mexico and Russia for a treatment that in the long-run could save the NHS loads of money. Scotland is one of the worst places in the world for MS yet in England you can get this treatment for free. Why arent we fighting in Scotland to get this?

Mrs Clarke added: Its very unfair. It just seems a no brainer to me why they wouldnt make it available not for all patients but for some. The Scottish Government said referral decisions were "for clinicians".

A spokesman said: "Whilst the vast majority of healthcare provided by NHS Scotland is delivered in Scotland, NHS boards can commission treatment in other countries on an ad hoc basis, particularly where highly specialised treatment is involved. Decisions to refer patients are for clinicians, based on agreed guidelines, which ensure best practice, equity of access and consistency of treatment for all patients.

"HSCT is not currently widely available anywhere on the NHS, but people from Scotland can participate in trials held in other centres across the UK, where clinically determined appropriate and beneficial."

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Anger as Scots patients miss out on 'breakthrough' stem cell therapy ... - Herald Scotland

Reader Charles Wang wrote to ask if stem cell therapy - the use of stem cells to treat various medical conditions - is approved in Singapore. Mr Wang also asked where one could seek this treatment if it is available. Health reporter Linette Lai answered.

Any new treatment must be backed up by sufficient scientific evidence to ensure that it is safe and effective. However, there is still not enough scientific evidence available for stem cell therapy to be approved as a mainstream treatment in Singapore.

A Ministry of Health spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments, and it is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it would have to be conducted within the context of clinical trials."

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Is stem cell therapy approved in Singapore? - The Straits Times

When 14-year-old Aarav Gulati (name changed on request) met with an accident a couple of years ago while playing football, he injured his knee. A portion of the cartilage was damaged, and doctors used turned to a radical new procedure for a solution. They took Gulatis own cells, grew them in a lab and used them to replace the cartilage and repair the damage in a natural way.

He was an ideal case for the use of regenerative cell therapy that was a fairly new phenomenon in orthopaedic treatment in India, says Dr Yash Gulati, senior joint replacement and spine surgeon, New Delhis Indraprastha Apollo Hospital.

The regenerative cell therapy got US FDA approval this year, and the Apollo group partnered with RMS REGROW, a company that specialises in cell therapy technology, to exclusively offer the treatment to patients in India.

Instead of using artificial implants, the technique helps in healing the bone or cartilage damage in a natural way using a persons own cells to regain normal function. Cultured cells (grown in a lab) are injected into a patient to replace diseased or dysfunctional cells.

Instead of using artificial implants, the technique helps in healing the bone or cartilage damage in a natural way using a persons own cells to regain normal function. Cultured cells (grown in a lab) are injected into a patient to replace diseased or dysfunctional cells. (Illustration: Siddhant Jumde)

A small part of the joint cartilage is taken through a keyhole procedure, and is grown in a special manner to convert it into stem cells in the laboratory, says Dr Gulati. This is then applied on the area showing loss of joint cartilage.

Dr Gulati has so far treated 10 people using this therapy in Apollo, Delhi.

Stem cells lead to growth of joint cartilage in defective areas, and normal new cartilage re-grows. In bone damage, bone marrow cells are harvested, cultured and implanted in the area to be able to re-grow in a healthy way, Dr Gulati says.

In Mumbai, those in need of joint replacement because of injury, wear and tear or other lifestyle and ageing, are also realising that new cartilage can be grown in a lab from ones own cells and used instead of artificial materials.

Chondron or cartilage cell therapy is a patient-specific regenerative medical treatment which naturally regrows original cartilage. The therapy is used for repairing articular cartilage of the knee, ankle and shoulder joints and to help replace missing areas of cartilage.

This is a process where a biopsy of cartilage cells (chondrocytes) is taken from the patients knee, ankle or shoulder, says Satyen Sanghavi, chief scientific officer of Regenerative Medical Services Regrow, a biotechnology company in Mumbai.

Causes of bone or cartilage damage

They are then cultured to grow and multiply in a lab for 3-4 weeks into a surplus population of several million. The cultured cells are then re-implanted in the damaged area in a minimally invasive surgical procedure.

The process comes from eight years of work in cell and tissue therapy research. Chondron ACI is the countrys first cell therapy product.

These cells grow and repair tissue with properties similar to that of normal cartilage present in other joints, says Sanghavi. But replacement alone doesnt solve problems. Patients are expected to follow a rehabilitation program, to help the body adjust to new cells and them get back to day-to-day physical.

Its easy to see the advantages of a process like this. Experts say it may avoid the need for future prosthetic joints replacement (especially partial joint replacement) and allows patients the freedom to continue physical activities as before.

It also poses less risk of disease transmission or infection since it comes from the patients own tissue (no foreign material or metal goes inside the body). It may also halt further progression to osteoarthritis, a common problem with those in need of joint replacement.

The procedure costs Rs.3 to 3.5 lakhs.

In India, more than 500 patients have been treated with both bone and cartilage cell therapy procedures, says Sanghavi.

There is a success rate of more than 95%. During our clinical trials and research, we have treated working professionals, housewives, athletes, army men and mountaineers. Almost all of them have successfully recovered and got back to their active life.

However, this new technique has a flip side, too.

The price could be a bit steep for some because stem cell treatment is expensive; and the treatment gets prolonged as a patient has to wait for some time as cell culture takes time and one cannot bear weight on the affected area while the healing is on. Also, not all patients are suitable for it because it can correct only if damage isnt extensive, says Dr Ankit Goyal, associate professor, Safdarjung Sports Injury Centre (SIC) in Delhi.

Safdarjung Hospital had also treated about 35 patients, who had damaged their cartilage, with the technique a few years ago.

We would send cartilage for culture but only in cases where damage was limited. This is definitely not a substitute for knee or hip replacement procedure where the entire joint is extensively damaged. However, it may prevent the need for replacement later on in life, especially in young patients, he says.

Continued here:
Damaged bone or cartilage? Now, grow your own cells in a lab - Hindustan Times

TissueGene has been awarded a $750,000 clinical grant from the Maryland Technology Development Corporation (TEDCO) via the MSCRF. The clinical grant is to be used for conducting clinical trials in Maryland using cell therapy. This money is part of Accelerating Cure, a new TEDCO initiative to support regenerative medicine and cell therapy technologies in Maryland.

The grant award will be used by TissueGene to fund a component of a clinical study at a Maryland location for its US Phase III clinical trial for Invossa. The ultimate outcome of this study is the verification that Invossa exerts its therapeutic effect not only by tissue regeneration but on other inflammatory aspects of the disease such as synovitis.

The title of the grant is "Assessment of the Efficacy of TG-C in Treating Synovitis Using Contrast Enhanced MRI in a Clinical Study of Knee Osteoarthritis." The Principal Investigator (PI) for the study will be Dr. Gurdyal Kalsi, Chief Medical Officer of TissueGene.

"We are excited to support this important clinical trial and the growth of TissueGene in Maryland," said Dr. Dan Gincel, TEDCO's VP University Partnerships, and MSCRF's Executive Director. "We look forward to see many more patients treated and cured from this and other devastating diseases."

Woosok Lee, CEO of TissueGene stated, "As a Maryland-based company, TissueGene is honored by the grant award from the State of Maryland which has consistently demonstrated its commitment to supporting innovative therapies such as Invossa, which could potentially be the world's first disease-modifying drug for treating osteoarthritis."

Invossa is a first-in-class osteoarthritis drug designed to conveniently and effectively treat osteoarthritis of the knee through a single intra-articular injection. Clinical trials completed in Korea and on-going trials in the US have demonstrated pain relief, increased mobility, and improvements in joint structure offering substantial convenience for the nearly 33 million Americans with osteoarthritis who would otherwise be in need of surgery.

TissueGene, Inc. TissueGene, Inc., is a Maryland-based regenerative medicine company specializing in cell and gene therapy. TissueGene's lead product is Invossa, an allogeneic, cell and gene therapy for osteoarthritis of the knee that has completed Phase II clinical trials in the US. TissueGene has recently reached an agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment (SPA) for a Phase 3 clinical trial for Invossa. Information can be found at the NIH registry, ww.clinicaltrials.gov. For additional information about TissueGene, Inc., please visit http://www.tissuegene.com.

The Maryland Stem Cell Research Fund (MSCRF) was established by the State of Maryland under the Maryland Stem Cell Research Act of 2006 to promote State-funded stem cell research and cures through grants and loans to public and private entities in the State. Administered by The Maryland Technology Development Corporation (TEDCO), the MSCRF is overseen by an independent Commission that sets policy and develops criteria, standards and requirements for applications to the Fund. For more information about the Maryland Stem Cell Research Fund, please visit http://www.mscrf.org.

The Maryland Technology Development Corporation (TEDCO) is the go-to source for entrepreneurial support and guidance for technology start-ups and early-stage companies engaged in bringing innovative ideas to market. For over nineteen years, the organization has provided funding, mentoring and networking opportunities to support Maryland's innovation ecosystem. It is frequently ranked as one of the most active seed/early-stage investors in the nation. The organization plays a key role in bringing research created in Maryland's educational institutions and federal laboratories into the commercial marketplace. For more information on TEDCO and its programs and resources, visit http://www.TEDCO.md.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/tissuegene-awarded-750000-maryland-stem-cell-grant-for-invossa-clinical-study-300482506.html

SOURCE TissueGene, Inc.

http://www.tissuegene.com

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TissueGene Awarded $750000 Maryland Stem Cell Grant for Invossa Clinical Study - PR Newswire (press release)

Genome editing specialist Cellectis has kicked off clinical tests in the US for the very first of-the-shelf CAR-T cell therapy in acute myeloid leukaemia.

The company said it enrolled the first patient with acute myeloid leukaemia (AML) to be treated with UCART123 at Weill at Cornell Medicine, New York Presbyterian Hospital. UCART123 is a TALEN-genome edited chimeric T cell receptor targeting the CD123/IL3R antigen on the surface of blasts and dendric cells, which is administered on allogeneic donor T cells. The team of Gail J. Roboz will investigate the safety and will collect first indications for efficacy of UCART123 in patients with AML. The Phase I trial is part of a strategic translational research alliance that was formed between Cellectis and Weill Cornell Medicine in 2015.

While Novartis AG and Kite Pharma are leading the CAR-T cell therapy development in AML, Cellectis hopes to overtake its competitors. It has the only approach that works with allogenic CAR-engineered T cells that could be centrally pre-manufactured in contrast to the autologous patient T cells. Those need to be isolated, engineered and expanded during the at least 14 day hospital stay of the patients to be treated making the procedure costly, lengthy and laborious. On the other hand, Cellectis therapy does not target the CD19 T cell antigen but CD123//IL3R giving the company another unique selling point.

Cellectis has used TALEN technology to block expression of the TCRa constant (TRAC) gene though blocking expression of the natural TCR. According to Andr Choulika, Cellectis CEO, TALEN technology shows less off-target effects compared to CRISPR/Cas9 genome editing. Following apheresis, donor T cells are engineered to express an anti-CD123 CAR (CD123 scFv-41BB-CD3z) and an RQR8 depletion ligand that confers susceptibility to rituximab. Theoretically, specifity of of UCART123 therapy might be higher in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) than in patients with AML as CD123 expression is 10fold higher in the precursors of plasmacytoid dendritic cells than in blast occurring in the course of AML.

Cellectis also announced two new entries to ists Board of Directors. Ex-Novartis pharma division head Rainer Boehm will lead commercialisation of Cellectis lead candidate. Ex Novartis Oncology President and Incyte Corp CEO Herv Hoppenot will lead clinical development.

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AML: Cellectis testing allogenic CAR-T cell therapy - European Biotechnology

Sangamo Therapeutics (SGMO) is a $650 million dollar market cap company focused on gene and cell therapies, including conducting the first-ever genome editing studies in clinical trials. The company uses gene therapy, genome editing, cell therapy, and gene regulation techniques to develop novel therapies. In gene therapy, attenuated Adeno-Associated Viral ((NYSE:AAV)) delivery systems are employed to carry functional gene copies to patients suffering from an ineffective or absent protein causing a disease state, such as in Hemophilia A (in collaboration with Pfizer (NYSE:PFE). The company is developing genome editing technologies for Hemophilia B and various lysosomal storage disorders, employing zinc finger nucleases (ZFN) to knock out harmful, defective, or unwanted proteins and also to insert helpful donor genes. The company is also utilizing gene editing and cell therapy techniques (T cell and stem cell) to treat HIV, and is partnering with Bioverativ (BIVV) to develop stem cell treatments for beta-thalassemia and sickle cell disease. Cell therapy can be used in conjunction with ZFN technology after harvesting afflicted cells, treating, testing for desired effects, cultured, then reinfused into the patient. Because ZFPs are the most common DNA binding motif in transcription factors of eukaryotic systems, gene repression or activation systems can be generated. SGMO is pursuing in central nervous system afflictions such as Huntington's Disease (in collaboration with Shire (SHPG)), by using specific gene repression of mutant disfunctional HTT gene but leaving functional gene products unchanged. Sangamo is attacking Alzheimer's and various tauopathies utilizing the same approaches. The company is also advancing non-therapeutic technologies with Sigma-Aldrich Corporation and Dow AgroScience.

Pfizer is a leading developer of AAV-based technologies. SGMO and Pfizer's collaboration in hemophilia A in May 2017 to develop AAV-based drug candidate gene therapy SB-525, one of Sangamo's four lead drug candidates, has received orphan drug status and fast track from FDA and EMA, and was perceived by the market as a big boost of confidence for Sangamo. The stock is up over 100% since the announcement. Pfizer made an initial payment of $70 million with up to $475 million in potential milestones, with $175 million potential for additional gene therapies if opted by Pfizer. Mikael Dolsten, president of worldwide research and development at Pfizer, stated, "We believe SB-525 has the potential to be a best-in-class therapy" that could provide stability to patients "with a single administration treatment." SGMO ZFN technology had recently been overshadowed in market sentiment by next-generation genome-editing technologies such as CRISPR prior to the announcement.

The company announced in the first quarter 2017 that it had received orphan drug designation (ODD, previously attained) and fast track designation from FDA for genome editing treatment SB-FIX for Hemophilia B. SGMO also progressed in lysosomal disorders by obtaining Rare Pediatric Disease Designation for in vivo genome editing treatment SB-318 for MPS I. In this disorder a deficiency in alpha-L iduronidase results in toxic buildup of glycosaminoglycans. According to the 2017 first quarterly report, "a sponsor who receives approval for a new drug application or biologics license application may be eligible to receive a voucher for a priority review of a subsequent marketing application for a different product. The voucher may be used by the sponsor or sold or transferred." SB-318 had also previously received ODD. The company also received ODD and Rare Pediatric Disease Designation for in vivo genome editing treatment SB-913 for MPS II (Hunter's disease). In this disorder, iduronate-2-sulfatase deficiency results in the buildup of glycosaminoglycans as well.

Sangamo's ZFN-mediated genome editing program for sickle cell disease and beta-thalassemia hemoglobinopathies transferred to Bioverativ in November of 2016, as part of a 2014 deal with Biogen. Bioverativ spun off from Biogen in early 2017 as a separate entity with specific experts to handle transformation of therapies for these rare diseases. Experts in related blood diseases hemophilia A and B medications will oversee sales and marketing of its lead products ELOCTATE and ALPROLIX respectively, as part of the responsibilities of the company.

Sangamo is using ZFN-mediated genome editing in the HIV space as well. Sangamo Therapeutics' approach inserts a naturally occurring human mutation which renders individuals largely resistant to HIV into T-cells and is monitoring patients in an open label phase 2 trial. Sangamo's SB-728-T HIV drug candidate targets the most common form of HIV. A Phase 1/2 clinical trial is also being conducted to evaluate safety and efficacy of its stem cell candidate, SB-728-HSPC, in HIV patients.

At the preclinical level, in vitro human culture and animal model data demonstrated significant reduction of tau mRNA and tau protein expression using ZFP transcription factor-mediated gene regulation technology. Results from the laboratory studies were presented at the 13th International Conference on Alzheimer's & Parkinson's Diseases.

Sangamo recently raised approximately $72 million in a public offering June 21, 2017, at $7.25 per share. An analyst at Jefferies was recently impressed by the company's presentation at a conference, and set a $17 per share price target on the SGMO shares. The company says it plans to use the funds to develop genomic therapy product candidates and potentially acquire complementary businesses, technologies, or licenses. Additionally the analyst said that this stock can serve as a financial investment hedge against the emerging gene-editing technology of CRISPR.

The gene editing and cell therapy spaces are definitely unproven to some extent and risky. There is also competitive risk in that this company is going up against some of the best regarded technologies in a tough field of gene and cell therapies that are possibly further advanced, including CRISPR. However, the risks are higher for Alzheimer's and HIV than for more straight-forward indications such as Hemophilia A. Pfizer's $70 million stamp of approval should reinforce that argument. Given the high quality partnerships for SGMO and relatively diverse pipeline, the reward to risk ratio should be adequate for a long position at these prices. The company is still in early to mid-stage trials, but a breakthrough in a rare or fatal indication could be an inflection point for the stock.

As of end Quarter one the company estimated $132 million in cash, taken with the recent offering of ~$70 million and estimated quarterly burn rate of ~$30 million leaves about $170 million in cash. This is a significant cash runway but given the immaturity of the clinical trial pipeline it is hard to predict if more dilution will be necessary in coming years. With only about $3 million in quarterly revenues trickling in its doubtful that the company can go without diluting if something were to go wrong. However, with its nice strategic partnerships and potential milestones from Pfizer, if things go well in the Hemophilia A project the company could near a cash neutral position within a couple of years.

Strong Bio regards this stock as a great watchlist stock, with intent to invest on significant pullbacks over time. Future clinical trial updates that indicate novel and robust responses could indicate FDA breakthrough therapy designation-worthy therapies. Of particular interest to Strong Bio are the projects of Alzheimers, HIV and cancer, as they have potential to show strong benefit in large markets. However, waiting too long might put investors in a "pay over the top" position as the more lead project Hemophilia A, B, and HIV projects progress. Strong Bio targets an entry in the $6.75 range.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Is Sangamo Therapeutics Pointing Toward Success? - Seeking Alpha

With numerous different entities and millions of people affected, cancer continues to be one of the most prevalent diseases around the world.

Scientists are working to find new treatment possibilities, and have been concentrating on the bodys own immune system for some time.

Because cancer emerges from the bodys own cells, it is usually difficult for the immune system to distinguish good cells from bad ones, explains Prof Dr Elfriede Nner, head of the Tissue Control of Immunocytes Research Group at the Helmholtz Zentrum Mnchen. But there are ways to support the immune system in recognizing and combating cancer cells.

Focus on T-cell therapy

One approach is the so-called adoptive T-cell therapy, which involves removing immune cells from the body and genetically arming them.

The cells are given new structures on the surface that accurately lead them to the cancer cells.

One limitation in this form of therapy is that the binding between the immune cell and the cancer cell is often somewhat weak.

Although this binding can be artificially strengthened, doing so also increases the risk of unwanted binding to healthy structures in the body, explains study leader Nner. She and her team were therefore searching for a different way to improve the defence provided by the immune cells.

Attack instead of sleep mode

In the current work, the researchers present a new surface molecule which comprises two halves.

On the outside, it preferentially binds to the PD-L1 molecule, which tumour cells often form in order to thwart the attacking immune cells.

On the inside of the T-cells, however, this binding does not activate a sleep mode (which the natural protein would do), and instead activates the T-cells killer programme, making it especially aggressive.

Experimental models showed that T-cells armed in this way proliferate more strongly in the tumours and destroyed more tumour cells.

The next step will be to confirm the findings in clinical studies.

If that step succeeds, the approach would enlarge the arsenal of T-cells suitable for adoptive T-cell therapy, Elfriede Nner states. This could not only make the treatment more effective but would allow it to be used in more patients in the framework of personalised medicine.

The work was the result of close cooperation with the team headed by Dr. Matthias Leisegang from the Institute of Immunology at the Charit Berlin Buch Campus and Prof Dr Dolores J Schendel, CEO and CSO at Medigene AG. The authors Ramona Schlenker, Luis Felipe Olguin Contreras, Anja Disovic and Julia Schnappinger attend the Helmholtz Graduate School Environmental Health, or HELENA for short.

Original Publication: Schlenker, R. et al. (2017): Chimeric PD-1:28 receptor upgrades low-avidity T cells and restores effector function of tumour-infiltrating lymphocytes for adoptive cell therapy. Cancer Research, DOI: 10.1158/0008-5472.CAN-16-1922

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New approach in T-cell therapy to treat cancer - Scientist Live

The Sartorius and Science Prize for Regenerative Medicine & Cell Therapy is focused towards scientists advancing research (basic or translational) within the relevant fields, with the winner receiving $25,000 in prize money and being published inScience magazine.

Scientists who have gained a PhD or an MD during the past decade are invited to submit an essay on regenerative medicine, cell therapy, gene therapy or immunotherapy, as well as on materials or tissue engineering. The essays should be 1,000 words in length and should describe the applicants research and implications for regenerative medicine and cell immunotherapy, as well as include supporting documents.

In addition to the cash prize and publication in Science, the winner will receive a Sartorius product package for free. Furthermore, up to three runner-up essays will be published in Science Online and the writers of the runner-up essays will also receive a cash prize of $5,000.

This area [regenerative medicine and cell therapy] will play a major role in the future, said Gerry MacKay, member of the Sartorius Group executive committee and executive vice president of marketing, sales and services for Sartorius Lab Products & Services Division. Sartorius innovative bioanalytical tools help scientists answer fundamental and complex biological questions. We are excited to enable medical progress in these fields, both with our technologies and this award. The prize will be conferred as a token of appreciation to scientist.

Science is delighted to join Sartorius in awarding a prize in the exciting area of regenerative medicine and cell therapy, added Valda J. Vinson, deputy editor research of Science. We look forward to promoting basic or translational research in fields ranging from gene therapy to materials engineering, which has the potential to improve human health.

Applications will be accepted until 1 October and the awards ceremony will be held in 2018 in Goettingen, Germany.

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Sartorius and Science to award a prize for regenerative medicine and cell therapy - EPM Magazine

Reader Charles Wang wrote in to ask if stem cell therapy is approved for use in Singapore. Stem cell therapy refers to the use of stem cells to treat various medical conditions. Mr Wang also asked if it is available, where can one seek this treatment?

Health reporter Linette Lai answered.

Any new treatment must be backed up by sufficient scientific evidence to ensure that it is safe and effective. However, there is not yet enough scientific evidence for stem cell therapy to be approved as a mainstream treatment in Singapore.

There is not yet enough scientific evidence to ensure that stem cell therapy is safe and effective for it to be approved as a mainstream treatment in Singapore. PHOTO: ST FILE

A Health Ministry spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments and is not available as a treatment in our public hospitals.

"If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it will have to be conducted within the context of clinical trials."

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askST: Is stem cell therapy available in Singapore? - The Straits Times

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Gosselies, Belgium,26 June 2017; 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces that the European Patent Office (EPO) has notified the Company of its intention to grant a key patent covering its first-in-class allogeneic cell therapy technology.

Once granted, the patent titled, Osteogenic differentiation of bone marrow stem cells and mesenchymal stem cells using a combination of growth factors, will provide legal protection to Bone Therapeutics both for the manufacturing methods and for the distinct cell type used in its allogeneic cell therapy technology. Specifically, the patent covers methods to manufacture differentiated and biologically active osteoblastic (bone-forming) cells from bone marrow stem cells, using a specific combination of growth factors, and also covers a new class of osteoblastic cells suitable for allogeneic administration to the patient.

Bone Therapeutics will now validate the patent in several countries in the European Union, potentially allowing IP protection for its allogeneic bone cell therapy platform until 2029. Patents from the same patent family have already been granted in Japan, Australia and Singapore and applications are pending in the USA, Canada, India and South Korea. ALLOB, Bone Therapeutics most advanced allogeneic bone cell therapy product, is currently being evaluated in Phase I/IIA clinical trials for delayed-union fractures and spinal fusion, for which interim results are expected in the third quarter this year.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: This notice from the European Patent Office confirms our allogeneic bone cell therapy technology is both innovative and distinctive. When granted, this European patent will significantly strengthen our IP position in the field of bone cell therapy, giving us further validation for the scientific and commercial development of our cell therapy products whilst also enhancing our position with respect to new partnerships.

Dr. Miguel Forte, Chief Medical Officer of Bone Therapeutics, further noted: Obtaining this patent is an important step in the development of our allogeneic bone cell therapy technology. It will provide a solid IP protection for our current work and for future technological advances, allowing us to continue our efforts to create patient-centric and commercially interesting bone cell therapy solutions.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation. Our technology is based on a unique, proprietary approach to bone regeneration which turns undifferentiated stem cells into osteoblastic, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery. Our primary clinical focus is ALLOB, an allogeneic off-the-shelf cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB, obtained from patients own bone marrow and currently in Phase III development for osteonecrosis and non-union fractures.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate coveringnine patent families. Further information is available at: http://www.bonetherapeutics.com.

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 thispress 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.

Josh Sandberg has been an executive search consultant focused exclusively on orthopedic and spine start-ups since 2004. He has had a tremendous impact in helping his clients avoid costly hiring mistakes by his deep industry knowledge and network. In 2010, Josh co-founded Ortho Spine Companies, which is the parent company of Ortho Spine Distributors (OSD), Surg.io and Ortho Sales Partners (OSP). OSD a searchable database that helps ease the frustration of finding orthopedic distributors throughout the country. Surg.io is the ultimate distributor toolkit that offers distributors the tools necessary to build the foundation of a scalable and highly functioning sales organization. OSP is an end-to-end solution that helps companies approach the Global Market in a cost efficient way. Our team has hundreds of years of experience and can help you navigate the many challenges present in bringing new technologies to the market.

Original post:
Bone Therapeutics receives Intent to Grant Notice from European Patent Office for allogeneic bone cell therapy platform - OrthoSpineNews