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Miami Project Gets Green Light to Begin Schwann Cell Human Trial | Miller School of Medicine | University of Miami
By Dross at 2012-08-05 03:46
Miami Project Gets Green Light to Begin Schwann Cell Human Trial | Miller School of Medicine | University of Miami

 The Miami Project to Cure Paralysis, a Center of Excellence at the University of Miami Miller School of Medicine, has received permission from the Food and Drug Administration to begin a revolutionary Phase 1 clinical trial to evaluate the safety of transplanting human Schwann cells to treat patients with recent spinal cord injuries.
 

Found mainly in the peripheral nervous system, Schwann cells are essential to sending appropriate electrical signals through the nervous system, and Miami Project scientists and supporters believe they are key to finding cures for paralysis. In what will be the only FDA-approved cell therapy-based clinical trial for sub-acute spinal cord injury in the United States, investigators plan to transplant a patient’s own Schwann cells at the injury site in the hope of determining the safety of the procedure which will allow further trials to proceed. 

“We believe today’s announcement is just as important to our field as man’s first step on the moon was to the space program,” said neurosurgeon Barth Green, M.D., Co-Founder and Chairman of The Miami Project. “When we started The Miami Project, the short-term goal was to improve the quality of life of people living with paralysis, but the long-term goal remains re-establishing function and finding a cure. Today the scientists, clinicians, and technicians who have made this day possible have taken a giant leap forward. The hundreds of millions of dollars and incalculable hours of bench and clinical work invested in this goal have been well spent.” 

“This is truly one small Schwann cell for a human, and one giant leap for humankind and the search for cures for paralysis,” said Pascal J. Goldschmidt, M.D., Senior Vice President for Medical Affairs and Dean of the Miller School of Medicine, and CEO of UHealth-University of Miami Health System. “The FDA decision validates the commitment of a family who has turned their own tragedy into hope, and the vision of scientists who have never wavered in their quest to reverse the catastrophic consequences of spinal cord injury.”

 Nick Buoniconti, Co-Founder of The Miami Project, said, “It has been 26 years since my family made a promise to Marc and all those living with paralysis that nothing will stand in the way of us finding a cure, absolutely nothing. FDAapproval of this clinical trial is allowing us to follow through on this incredibly important commitment that impacts millions of families each day. This validation of the tireless efforts being undertaken at The Miami Project offers real hope and shows we are closer than ever to curing paralysis.” “Back in 1985, all we had was Dr. Green’s dream, my family’s determination, a lot of hope, and a ton of hard work ahead of us,” said Miami Project President Marc Buoniconti. “To be at this point today, receiving FDA authorization for this Schwann cell trial, is so rewarding to me, my family, and everyone who has ever stood by our side and supported this important work. This is another of the many monumental steps we’ve undertaken these past 26 years that will lead us to our ultimate goal of curing paralysis.”

 

Led by W. Dalton Dietrich, Ph.D., the Schwann cell clinical trial team at The Miami Project is composed of a multi-disciplinary group of basic science and clinical faculty members, scientific staff, and regulatory personnel focused on advancing the trial. “Obtaining clearance from the FDA to initiate this important Phase I clinical trial is a vital step for the field of SCIresearch, and for the Miami Project team that has been working diligently on this therapeutic concept for more than a quarter of a century. This trial, when completed successfully, will lay the critical foundation for future cell-based therapies we plan to target SCI,” said Dr. Dietrich, Scientific Director of The Miami Project.

 The clinical trial will enroll eight participants with an acute thoracic SCI. Newly injured patients brought to the trauma center would have to meet the stringent criteria and agree to participate in further screening within five days of their injury. At that point, the participant will undergo a biopsy of a sensory nerve in one leg to obtain his or her own Schwann cells. The Schwann cells will then be grown in a culturing facility for three to five weeks to generate the number of cells necessary for transplantation, and to undergo the strict purification process. By the time the Schwann cells are surgically transplanted into the injury site, participants will be 26-40 days post-injury. All procedures will be conducted in Miami at University of Miami Hospital, Jackson Memorial Hospital, and The Miami Project to Cure Paralysis. Each participant will be followed intensely for one year after receiving the transplantation surgery, and their neurologic status, medical status, pain symptoms, and muscle spasticity will be evaluated. It is expected that it could be at least two to three years from the time the first subject is enrolled until the final subject is one year post-transplantation. All participants will continue to be monitored for years under a separate clinical protocol. This Phase I trial is the foundation upon which The Miami Project will develop future trials targeting different types of injuries, times post-injury, and therapeutic combinations. 

The Miami Project has developed life-enhancing SCI programs used by hospitals and clinics across the nation and around the world. For example, male fertility for paraplegics and quadriplegics was a research effort and is now clinical practice; the monitoring of a patient’s spinal cord in the operating room was a concept, and is now an FDA-approved reality; the use of functional electrical stimulation in rehabilitation of paralyzed or partially paralyzed muscles is now FDA-approved and effective because of work by The Miami Project; the use of computerized walking systems is now FDA-approved; and the use of cooling to protect the nervous system is now an approved and commonly used practice in cardiology and vascular surgery and is rapidly being advanced in the areas of brain and spinal cord injury due to the work of The Miami Project.  



1 comment | 2134 reads

by gdpawel on Mon, 2013-01-28 21:12
Unique human in vitro model (cell culture) research currently underway at the Peninsula Medical School in the South West of England is set to identify and develop therapies for the treatment of multiple tumours in the brain.

The tumours are caused by mutations affecting a protein called merlin, which in turn cause cancers in a range of cell types including Schwann cells in the brain. Schwann cells produce the sheaths that surround and insulate neurons.

Although the tumours are benign, they are frequent, can be inherited and come in numbers. The sheer number of them can overwhelm a patient, often leading to deafness and eventually death. Patients can suffer from 20 to 30 tumours at any one time, and the condition typically affects older children and adults.

No therapy, other than invasive surgery aiming at a single tumour and which may not eradicate the full extent of the tumours, exists.

The condition of multiple tumours is known as neurofibromatosis type two (NF2) and affects one in every 2,500 people worldwide. It can affect any family, regardless of past history, through gene mutation and currently there is no cure.

Research at the Peninsula Medical School is led by Professor Oliver Hanemann. By working with human cells in vitro, Professor Hanemann and his team are able to find new therapeutic targets for NF2. They have secured initial success by re-profiling an existing drug, Nexavar (sorafenib), and because they are using the human in cell culture model and re-profile new cancer drugs they do not need to carry out huge toxicity studies - which means they now can go straight to clinical trials and introduce therapies to patients sooner rather than later using Nexavar (sorafenib) or similar drugs.

Said Professor Hanemann: "Ours is a unique model and a unique approach to the issue. We are on the verge of working with inpatient clinics to trial our latest breakthrough, and we are investigating other therapeutic targets using other drugs."

He added: "Using human in vitro cell culture, which is the unique aspect of our work, allows us to move seamlessly and relatively quickly from lab-based biochemistry to drug therapies, clinical trials and hopefully successful outcomes."

Maria Toman, chair, the Neurofibromatosis Association, commented: "The Neurofibromatosis Association ([url]www.nfauk.org), as the only charity working in the UK with patients and families affected by neurofibromatosis, welcomes this breakthrough heralding the possibility of new, non invasive treatment for NF2 with the potential to transform management of this debilitating and long term condition, and will be watching progress of the trials with close interest. Our members have benefited hugely from Professor Hanemann's clinical work since his arrival at the Peninsula Medical School and by his establishment of the first specialist neurofibromatosis clinic in the South West of England. We hope that similar approaches in neurofibromatosis type one, one of the commonest genetic diseases, will bring treatment trials in the near future."

Dr. Kim Hunter-Schaedle, chief scientific officer of the Children's Tumor Foundation said: "Dr. Hanemann's work is very exciting. There is currently no effective treatment for neurofibromatosis. As a physician and researcher he should be able to take positive results quickly from the bench to the patient, getting promising neurofibromatosis drug therapies as quickly as possible into clinical trials. " The Children's Tumour Foundation has provided seed funding to Professor Hanemann and to an international consortium of research establishments of which the Peninsula Medical School is one. It will fund over $3 million for neurofibromatosis research programmes in 2008. More information is available by logging on at [url]www.ctf.org. More information is available by logging on at [url]www.pms.ac.uk

CASE STUDY

Tom Wakenshaw, 21, from Gunnislake in Cornwall, first became aware that there was a problem when he started to suffer from very bad headaches at age 15.

He was a pupil at Tavistock College at the time and in the middle of his GCSEs. He was referred for an MRI which identified a tumour on his brain, and was immediately rushed to Bristol for surgery to remove it.

Said Tom: "I had the operation, and then they told me afterwards that I had neurofibromatosis. When you're young you just take these things on board, which is what I did at the time. But it has had a huge effect on my life since."

Tom lives with his mother Val, and is currently being helped by the local Job Centre to try to find a job that can accommodate the effects of the neurofibromatosis. The condition causes him to get very tired and affects his balance. The operations he has had over the past years to remove more tumours have resulted in numb fingertips and feet.

He said: "I had a job as a window cleaner once, but a had an accident where a nail slipped between my toes. The worrying thing was that, even though it did not go into me, I couldn't feel it passing by my toes."

Tom is currently working with his local Job Centre which his finding him placements - his next is a six week spell working in the kitchen at the Bedford Hotel in Tavistock.

Tom is the youngest of four children, and some of his family live close by. Said Tom: "My Mum, Dad and brother live locally and see what it's like on a day-to-day basis. It's good to have them close by."

Tom attends the clinics run by Professor Oliver Hanemann at Derriford Hospital in Plymouth. "They're really useful, and a good opportunity to talk about how I'm doing," said Tom. "Professor Hanemann gives us good ideas and suggestions to help cope with the condition, and just talking about it is a great help."

Source: The Peninsula College of Medicine and Dentistry

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