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Clinical trial tests validity of utilizing microbiome manipulation to augment stem cell activity



BioTech Holdings has announced clinical safety data on three patients suffering from critical limb ischemia treated with the company's Procell microbiome-optimized personalized stem cell product. 

In the investigator-initiated pilot study, patients with diabetes-associated circulation deficit in the legs (critical limb ischemia) who failed previous treatments were administered their own bone marrow-derived stem cells that were treated with the company's proprietary microbiome-derived compounds. 

No treatment-associated adverse reactions were observed and patients were followed up for three months. Furthermore, two of the three patients had documented improvement in leg circulation and healing of ulcers that previously were not healing.

"It is well known that the microbiome controls many aspects of human health and disease ranging from obesity to autoimmunity to even neurological function," said Thomas E. Ichim, Ph.D, president and CEO of Biotech Holdings. "We are fortunate to have filed intellectual property on application of probiotics and microbiome manipulation to stem cells more than a year ago.  The current study supports our forward movement of our ProCell product to formal clinical trials."

Procell is comprised of bone marrow stem cells harvested from the patient that are treated with factors generated by the microbiome of healthy patients. The key ingredient that the company has identified as secreted by the microbiome that augments stem cell activity is already approved by the FDA for other indications. Accordingly, the company believes it is eligible for accelerated FDA registration pathways, including the 505b2 pathway.

The company said that it intends to develop the indication of critical limb ischemia as its first condition. Patients with this condition have a major amputation rate as high as 40 percent at six months and a mortality rate of 20 to 25 percent in the first year after presentation. Critical limb ischemia represents a market of approximately $10 billion per year.

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