BioTech Holdings Announces First Clinical Use of Microbiome Optimized Autologous Stem Cells
- Category: DNA RNA and Cells
- Published on Saturday, 08 July 2017 10:36
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Pilot Clinical Trial Supports Validity of Utilizing Probiotic / Microbiome Manipulation to Augment Stem Cell Activity
SAN DIEGO, CA, USA I July 7, 2017 I BioTech Holdings announced today clinical safety data on 3 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 3 months. Furthermore, 2 of the 3 patients had documented improvement in leg circulation and healing of previously unhealing ulcers.
"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 ago1. The current study supports our forward movement of our ProCell product to formal clinical trials."
The Company's product, Procell, comprises of bone marrow stem cells from the same 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 which 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 intends to develop the indication of critical limb ischemia as its first condition. Patients with this conditions have a major amputation rate as high as 40% at 6 months and a mortality rate of 20% to 25% in the first year after presentation. Critical limb ischemia represents a market of approximately 10 billion dollar per year2.
SOURCE: Biotech Holdings