Dr. Law's Response to "Myoblast Transfer Treatment- A Cautionary Tale"

• The World Alliance of Neuromuscular Disorder Associations (WANDA) quotes the report from a member who underwent MTT with very negative results. I would expect that out of the 240 muscular dystrophy (MD) patients whom we have treated in the past 12 years, one member may have negative results. Cell Therapy Research Foundation (CTRF) does not make diagnosis on patients. Diagnosis is always performed by certified neurologists who refer patients to CTRF. We ran many tests on our patients to confirm muscle weakness which is the most critical criterion of muscular dystrophy.

• The Mediterranean Society of Myology (MSM) states that MTT has been clearly shown to be ineffective. Once again, it is a statement not supported by any scientific evidence We have publications and many comments from our patients indicating that the procedure was effective, not only in muscular dystrophy but also in congestive heart failure.

• The Brazil Health Department has a mandate that if the country does not have a treatment for a particular disease, the government, specifically in Santa Catalina, has to provide supportive funds to allow the patient to travel to whatever country to participate in the best possible mode of treatment.

• More recently, a Brazilian journalist pretended to be the godmother (Maria) of a fictitious 7 year-old boy called Bruno whom she said had Duchenne muscular dystrophy (DMD). This journalist went into great depth to defame CTRF and myself with the purpose of preventing MD patients to come for MTT treatment. Tunja Jackson, CTRF Patient Coordinator, conducted a lengthy correspondence with her (Maria), requesting various interviews, tests, and medical records. She has submitted to CTRF fake medical records, reports of Brazilian government financial support, and even family death (the father) of the child so as to get Dr. Law condemned. The fictitious patient was never transplanted because he had never shown up for interview or pre-testing. Only a TENTATIVE schedule was made with this patient pending results of tests that we required. Why would someone act so maliciously?

• The MDI claims that none of the Brazilian children showed any improvement. In my opinion, the MDI stretched facts a little bit by claiming that, “In one case, it is possible that MTT may have accelerated the progression (of the disease)". There is no scientific data to support this statement. In addition, when the results were submitted for FDA to review at the end of the Phase II studies, the FDA put CTRF on "Fast Track" and encouraged Phase III Multi-center Clinical Trials instead of claiming that MTT may have accelerated the progression of the disease.

• To my knowledge, neither Terrence Partridge nor Victor Dubowitz has conducted Myoblast Transfer on a single patient but has made numerous non-scientific statements that MTT does not have therapeutic effects on MD. George Karparti made too many injections with too little myoblasts into a small muscle of a DMD child, thus ruining the muscle through traumatizing rather than rebuilding the dsytrophic muscle with myoblasts.

• In concluding remarks, the article touted physiotherapy, corticosteriods, and assisted ventilation as effective treatment in improving life expectancy and quality of life. None of these has gone through the scrutiny of FDA clinical trials or has been approved as treatment for MD. In fact, there are more side effects in corticosteriods than what they are worth.

To conclude, pioneering work always suffers from extreme scrutiny. The scrutiny of MTT on MD comes much more often from news media rather than scientific debate. It appears as if MTT’s success on MD and now on heart failure is posing a threat to some insecure groups that derive either livelihood or benefit from MD patients. CTRF and Dr. Law shall continue to be subjected to such defamation until clinical trials are completed which often take many years. Only the good science and medicine can see us through. This is true with all new inventions or business.

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Dr. Law’s Responses