Chara Biologics may offer non-compliant product
Chara Biologics fancies itself the premier source of alleged therapeutic peri-natal donor-derived products. They claim to be “…the forefront of regenerative medicine” and “The Medicine of the Future”. Imagine that, a company being the medicine of the future. Sorry to disappoint anyone taken in by the bombast, but the reality is much less than the...
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Contaminated Umbilical Cord Blood
Over the past three posts (Part One, Part Two and Part Three) I have cited sections of 21 CFR 1271 as they relate to the manufacturing of HCT/Ps, such as cord blood-derived products produced by Genetech and sold by Liveyon that resulted in 15 patients (so far) suffering often severe adverse events due to having...
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Liveyon Blames FDA
In the past two posts (Part One and Part Two) I have covered details about a serious lapse in quality control on the part of Genetech, the source of contaminated cord blood-derived products, which was injected into 15 patients who have developed serious infections, as tracked by the CDC. Genetech sold the donor-derived cord blood...
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Genetech Failure
In the previous post, I had begun to review the Warning Letter the FDA issued to Genetech, who was the supplier of cord blood-derived products to Liveyon, who in turn sold the contaminated vials of their product to physicians across the USA. While the most shocking observation the FDA made in the Warning Letter was...
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Genetech Provides Contaminated Donor-Derived Therapy
Recently, the CDC announced to the public the existence of an outbreak of infected patients who had received a donor-derived regenerative therapy in several states: “Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018.” It isn’t a...
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IRB-Approved Studies Scam
In response to a number of enquiries about companies selling miraculous stem-cell containing therapeutic products who are offering participation in an “IRB-cleared” clinical study, I would urge physicians to be cautious before signing up. In my opinion, there are a number of issues here, including smoke screens by companies that want to make a buck,...
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FTC Clinical Study Standards Patients
Over the past few posts, I have been reviewing the situation clinicians and others find themselves in if they want to make health-related claims about regenerative therapies currently in use by the community. The FTC has gotten a Federal court to embrace the requirement that health-related claims need to be based on results from Level...
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FTC Clinical Study Standards and Intraosseous Treatment
In the last post, I reviewed some of the issues and lessons from the Shapiro, et al. papers, as they related to doing higher level clinical studies with BMC. However, even their study didn’t meet the newly minted standard set by the FTC in the court Order issued last October. In that court Order, the...
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FTC Clinical Study Standards and Placebo Control
In the previous post, I had completed my review of the clinical findings published in a second paper by Shapiro, et al. confirming the utility of injecting saline into one OA-afflicted knee and BMC into the other OA-afflicted knee when treating patients with bilateral knee OA. Certainly, their approach is a novel way for treating...
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