SAN DIEGO, California. (February 27, 2009) Stemedica Cell Technologies, Inc. (“Stemedica”) provided its observations and comments to the media regarding the PLoS Medicine article published online February 17, 2009. The PLoS Medicine article describes a patient who developed “brain tumors” (glioneuronal neoplasms) after undergoing repeated transplants of “fetal neural stem cells” in Russia starting in 2001.
“All of us at Stemedica would like to extend our condolences to the young patient involved in this situation and our hope is for a speedy and positive outcome to this unfortunate experience. Never before have we or any of our Principal Investigators ever encountered such an occurrence either in our own research or in any of the published research”, said Dr. David Howe, Stemedica’s Vice President and Medical Director.
“We want to use this unfortunate incident to warn those seeking stem cell therapy abroad,” warns Dr. Nikolai Tankovich, President & Chief Medical Officer of Stemedica, “to make certain that the manufacturer of the stem cells used in transplantation comply with the rigid standards that have been established by the FDA and other Internationally-recognized regulatory agencies. The future of this industry and the safety of all future patients depend on such adherence.” FDA Compliance and Surveillance Standards can be referenced by visiting www.fda.gov/cber/compliance.htm.
The report in PLoS, Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient, describes the development of multifocal glioneuronal neoplasms along the spinal nerves and brain stem in a 13-year-old patient who underwent repeated transplantation procedures in an attempt to treat ataxia-telangiectasia (A-T). A-T is a progressive neurodegenerative disorder known to have an increased risk of developing cancer.
Malignancy and neoplasia are common in A-T secondary to deficient cellular and humoral immunity. This immune deficiency is a contra-indication to stem cell transplant therapy. In addition, the mutations associated with A-T in the A-T mutation gene lead to mutations in nuclear protein, which normally repairs DNA. This loss of DNA repair combined with immune deficiency in A-T increases risk of neoplasia with and without cellular transplant therapy in A-T.
“Due to age, children and adolescents have significantly increased quantities of growth factors. Adding stem cells, known for their growth factor production capabilities, to a child with this presenting condition may have been a contributing factor. As in the administration of pharmaceuticals, many of which are not recommended for use in children and adolescents in the same way as in treating adults, great care must be taken in using stem cell therapy with this population of patients”, said Dr. Michael Bayer, Stemedica’s Director of Medical Services.
Based on the facts and references cited within the PLoS Medicine article, researchers have discovered that some of the cells were female and had two copies of the gene that causes A-T. Karyotype testing was reported in this case which confirms inadequate testing of the stem cells prior to transplantation. “The stem cell preparation protocol provided to the parents by the treatment team was reviewed and found to be inadequate by our standards”, said Dr. Howe. “No cell characteristics, cell markers or bio-safety data was present. Mechanical desegregation in the 8-12 week age fetus is not recommended. Enzymatic separation is preferred, a process that also removes any dead cells that may be present. There is also a significant lack of detail on the number of cell passages as well as the dispersion of the neurospheres”, Dr. Howe went on to say.
Dr. Alex Kharazi, Stemedica’s Vice President for Manufacturing & Research observed, “Limited cell culturing in only 12-16 days as described in their protocol is like using a crude primary culture of cells. There are numerous risks associated with using crude cell preparations that have not been subjected to rigid manufacturing and testing protocols such as purity, identity and potency. In addition, the antibiotics used to manufacture the stem cells, are potentially neurotoxic.” Dr. Kharazi went on to say, “Overall the description provided for the manufacturing protocol was vague and a poor example of what a well thought out manufacturing and safety-driven process should be. For example, there was no data provided relating to tumorgenicity, toxicity, or bio-distribution testing of the manufactured cells in nude mice which is a mandatory requirement as a first and critical step to assessing cell safety.”
“Stemedica is committed to a manufacturing process that puts safety first at all times. Our stem cell product lines go through extensive testing during several stages of the manufacturing process and are also subjected to in-depth pre-clinical studies before filing with the FDA and other regulatory agencies for clinical trials”, continued Dr. Kharazi. “Nothing is more important than the welfare of the patient and there is no explanation that can justify any deviance from compliance to FDA guidelines for the manufacturing and testing of stem cells prior to administration. These are the guidelines we follow and any patient considering stem cell therapy, at any location worldwide, should confirm that the manufacturer is in full compliance before they decide to undergo stem cell transplantation.” warns Dr. Kharazi.
About Stemedica Technologies, Inc.
Stemedica Cell Technologies Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Stemdedica complies with the standards and guidelines established by the FDA and the FDB (Food and Drug Board) in the manufacturing and testing of its stem cells. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative diseases, sight restoration and wound repair. Stemedica is based in San Diego, California.
