US FDA Green Lights Second Duchenne’s Muscular Dystrophy Patient To Receive Human Umbilical Cord Stem Cells In US
After several promising treatments in Panama using stem cell technology developed by Medistem Panama Inc. at the City of Knowledge in Panama, a 6 year-old Duchenne’s muscular dystrophy patient received his first umbilical cord tissue-derived mesenchymal stem cells in the US earlier this year following FDA approval of a second application for a single patient, investigational new drug (IND) for compassionate use.
Duchenne muscular dystrophy (DMD) is a rapidly progressive form of muscular dystrophy that occurs primarily in boys. It is caused by an alteration (mutation) in a gene, called the DMD gene, which causes the muscles to stop producing the protein dystrophin. Individuals who have DMD experience progressive loss of muscle function and weakness, which begins in the lower limbs and leads to progressively worsening disability. Death usually occurs by age 25, typically from lung disorders. There is no known cure for DMD.
This trial marks the second time the FDA has granted an investigational allogeneic stem cell IND for Duchenne’s in the United States.
Ryan Benton, the first DMD patient to be treated in the US with umbilical cord stem cells just celebrated his 30th birthday, a landmark age for any Duchenne’s patient. The FDA recently approved a request to increase Ryan’s treatments from two to three times per year. Since his treatments began in September 2014, Ryan’s condition has stabilized and there have not been any adverse side effects reported.
The new subject had traveled to the Stem Cell Institute in Panama several times for treatments similar to Ryan’s. Encouraging results and news of Ryan’s compassionate use trial prompted his parents to seek out a similar trial for him in the US, which was recently granted by the FDA.
Since 2007, The Stem Cell Institute has treated patients with human umbilical cord tissue-derived mesenchymal stem cells for autism, cerebral palsy, heart failure, multiple sclerosis, osteoarthritis, rheumatoid arthritis and spinal cord injury.
In Panama, the institute is currently providing clinical services for Translational Biosciences’ Institutional Review Board-approved phase 1/2 clinical trials for autism, MS, osteoarthritis, rheumatoid arthritis and spinal cord injury. It anticipates approvals for cerebral palsy and heart failure trials in the future. For more information about see: Translational Biosciences on ClinicalTrials.gov.
Renowned stem cell scientist Neil H. Riordan, PhD, developed the stem cell technology being utilized in this trial. Dr. Riordan is the founder and president of the Stem Cell Institute in Panama City, Panama, and Medistem Panama. Medistem Panama is providing cell harvesting and banking services for this trial.
The Aidan Foundation, a non-profit organization founded by Dr. Riordan in 2004 to provide financial assistance for researching unmet medical needs, is providing financial assistance for this trial.
About Stem Cell Institute Panama
Founded in 2007 on the principles of providing unbiased, scientifically sound treatment options; the Stem Cell Institute (SCI) has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, our comprehensive stem cell treatment protocols employ well-targeted combinations of autologous bone marrow stem cells and donor human umbilical cord stem cells to treat: autism, cerebral palsy, multiple sclerosis, spinal cord injury, osteoarthritis, rheumatoid arthritis, heart disease, and autoimmune diseases.
In partnership with Translational Biosciences, a subsidiary of Medistem Panama, SCI provides clinical services for ongoing clinical trials that are assessing safety and signs of efficacy for autism, multiple sclerosis, osteoarthritis, rheumatoid arthritis, and spinal cord injury using allogeneic umbilical cord tissue-derived mesenchymal stem cells (hUC-MSC) and hU-MSC-derived mesenchymal trophic factors (MTF). In the future, Translation Biosciences expects to expand its clinical trial portfolio to include heart disease and cerebral palsy.
For more information on stem cell therapy:
Stem Cell Institute Website: http://www.cellmedicine.com
Stem Cell Institute
Via Israel & Calle 66
Plaza Pacific Office #2A
Panama City, Panama
About Medistem Panama Inc.
Since opening its doors in 2007, Medistem Panama Inc. has developed adult stem cell-based products from human umbilical cord tissue and blood, adipose (fat) tissue and bone marrow. Medistem operates an 8000 sq. ft. ISO 9001-certified laboratory in the prestigious City of Knowledge. The laboratory is fully licensed by the Panamanian Ministry of Health and features 3 class 10000 clean rooms, class 100 laminar flow hoods, and class 100 incubators.
Medistem Panama Website: http://www.medistempanama.com
Medistem Panama Inc.
Ciudad del Saber, Edif. 221 / Clayton
Panama, Rep. of Panama
Phone: +507 306-2601
Fax: +507 306-2601
About Translational Biosciences
A subsidiary of Medistem Panama Inc., Translational Biosciences was founded solely to conduct clinical trials using adult stem cells and adult stem cell-derived products.
Translational Biosciences Web Site: http://www.translationalbiosciences.com