Regeneration Biomedical, Inc.
RBI, Inc. was started in 2018 after five years of Institutional Review Board (IRB) approved research by Christopher Duma, MD, FACS. a neurosurgeon who witnessed the birth of the human stem cell sector over their past 30 years of experience, saw its various successes and failures, and helped shape national stem cell policy. Time and direct experience have articulated core principles for RBI.
Dr. Duma’s work focused on treatments for neurodegenerative degenerative diseases using a patient’s own (autologous) stem cells, injected directly into the ventricular system of the brain. The concept of this work was that pharmaceuticals injected or taken intravenously into the human body, have very little chance of breaking through the “blood brain barrier.” By injecting stem cells directly into the ventricular system of the brain, this barrier is bypassed, and the cells reach the affected area of the brain via the extensive cerebrospinal fluid “canal” system and lymphatic system which reaches every nook and cranny of the brain.
For Alzheimer’s disease, as an example, all human test subjects were in the late stages of Alzheimer’s disease, with cognitive MMSE scoring as low as a 9 on a scale of 30. After one year of injection some are scoring at 19-20 out of 30 – a result that has yet to be seen with any existing FDA approved treatment. We see a leveling off or an improvement in scoring requiring booster shots are given every 2 months for the first 2 years, and then potentially at intervals farther apart.
Patients with the progressive form of multiple sclerosis saw improvement in their walking scores and plaque formation on MRI.
Our work has led to our proprietary patents pending in this field. We are now submitting our work for FDA IND approval for Phase 1/2 status. We are seeking funding for this submission and testing.
We have learned that transplantation into humans of stem cells or their differentiated progeny poses near insurmountable obstacles to commercial manufacturing, cost of goods, and regulatory approval.
We have learned that stem cell media and manufacturing methods underlie everything in our space. Thus, we developed proprietary media and proprietary manufacturing methods, over decades of work. These foundational tools allow us to establish purity of product, eliminate batch-to-batch variability of product, streamline quality and regulatory systems, and lower cost of goods.
And we have learned that emerging technologies must be led by the science. We don’t lock down manufacturing processes or product before everyone, from the stem cell scientist at the bench to the Board of Directors, deems them ideal. This allows us to match corporate goals with scientific reality, in a manner that has been suspiciously absent in the stem cell sector.
Rock solid science, rock solid brain surgery experience, addressing large market indications. This is Regeneration Biomedical, Inc.
