ALS (LOU GEHRIG’S DISEASE) PATIENT IMPROVES SIGNIFICANTLY AFTER STEM CELL THERAPY.
Stem Cell Pharma, Inc (SCPI) plans to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) claiming Orphan Drug status for its amniotic stem cell implant (the SCPI Implant) in the treatment of ALS.
1. Patient Improvements. DJB, Male 62 Years Old Had Received The SCPI Implant March 8, 2007 At A Medical Facility Abroad.
His report to us stating unusual improvements, six weeks after the implant, determined us to send a letter with details, to the ALS Association, asking them to designate a neurologist or team of experts to examine this patient, and compare the before and after, the stem cell therapy. This patient had been examined at the University of Pittsburgh end March 2006, where he went through Departments of Neurology, Radiology (MRI’s) Electromyograhy (nerve conduction and, Electromyography (EMG’S) and metabolic (Nutrition) and diagnosed with Progressive Muscular Atrophy (PMA) and ALS. He was advised that his condition made him a suitable candidate for amniotic membrane, (embryonic) stem cell therapy. When patient asked for a date for such therapy he was told it would happen in 6-7 years, since their research is progressing from rats to …pigs and more extensive research, would have to be carried out, before being used in humans.
2. Patient Claims Six Weeks After Implant-
According with his letter and comments made by phone. “During the first three weeks post implant I started to notice signs of improvement. There was a definite reduction in the frequency and intensity of fasciculations and cramping. Fine motor coordination returned to near normal level in my left hand and there was good improvement in my right hand ---being able to shave with my right hand helped by my left hand, able to pick up objects and hold them, being able to remove caps from bottles, buttoning and unbuttoning a shirt. Respiration function increased from weak and labored to a more normal level of breathing, circulation problems in my feet improved and the color changed from the blue/red to red/pink.”
“The incremental changes so noted could be an indication of movement towards remission. I trust my judgment is correct and will be confirmed by my neurologist at my next scheduled appointment on June 29, 2007.”
NOTE: We (SCPI) believe to be able to secure him an earlier appointment from the ALS Association.
3. SCPI to Apply to the FDA for an Orphan Drug Status
Based upon results from this ALS patient corroborated with two other ALS testimonials and after consulting literature re; ALS and stem cells, SCPI had decided to proceed with an Investigational New Drug (IND) application to the FDA, claiming Orphan Drug Status for the SCPI Implant. Orphan Drug Status is conferred by the FDA after a thorough examination of evidence, to drugs intended to treat diseases afflicting up to 200,000 patients. The cases of ALS in the United States are estimated at 30,000. An eventual approval of a Orphan Drug Status confers many advantages, less studies, and a shorter term of approval when compared with the amount of work needed to approve other new drugs.
SCPI had already contacted and signed preliminary documents with a tissue bank company, FDA approved for Good Tissue Practices (GTP), agreement that would provide the amniotic membranes we need and in accordance with our specifications.
Preliminary steps were also taken to secure the cooperation with a company specialized in designing FDA protocols, and take our company through the difficult task of proving our claims and eventually securing the FDA approval.
Contact
StemCell Pharma, Inc.
1701 East Katie Avenue #20
Las Vegas, NV 89119
Phone: (702) 383-5893
Fax: (702) 733-9505
