Under Section 361 of the Public Health Service Act, biologic products must meet the following four criteria: they are minimally manipulated; they are intended for homologous use; they do not involve a combination of cells and tissues with another article (with some limited exceptions), and they do not have a systemic effect and are not dependent upon the metabolic activity of living cells for its primary function [as per the July 2020 guidelines 21CFR Part 1271.10(a)].
It is generally accepted that bone marrow aspirate concentrate, when injected into an osteoarthritic joint, will mitigate the symptoms and functional impairments imposed by that inflamed joint. Present in the Bone Marrow Concentrate (BMC) are Adult Mesenchymal Stem cells, Precursor Cells, Platelets, Growth Factors, Exosomes, and more. What is still unproven is whether BMC in a skeletally mature patient results in cartilage regeneration or succeeds by an anti-inflammatory mechanism. Generally agreed upon is that the effect is orchestrated by a cellular mechanism. The success of an intraarticular bone marrow concentrate injection into an arthritic joint was documented in a 2018 publication in which I was the senior author.
The next step in the evolution of addressing the arthritic joint was a combined intraarticular and intraosseous approach for the arthritic joint based on the pioneering observations and research of Professor Philippe Hernigou, Paris France, wherein he treated structural defects in the subchondral bone, that is the bone supporting the arthritic cartilage, by injecting that structural bone with bone marrow concentrate. In a scientific article published by my team in 2020, in which I was the senior author, we reported the results of using Bone Marrow Concentrate for the cellular repair of the arthritic joint and for the structural repair of the bone supporting the joint (subchondroplasty).
On Wednesday, our team began exploring and planning an observational clinical trial to study the results of treating the cartilage, bony, and articular defects in the osteoarthritic joint with a structural repair approach via the application by a syringe of acellular collagen. The observational study will be under the auspices of an IRB to make sure we are FDA compliant. The inclusion criteria will be established and those patients who are not able to participate in the next FDA approved Personalized Stem Cell Trial will be offered the opportunity to enroll in the Structural Application Trial.
To schedule an office visit, call (847) 390-7666. You may learn more by visiting our website at www.sheinkopmd.com but the update with the structural approach has not yet been built out so it will require a phone call or office visit. Those interested in the PSC Trial may follow the announcement at www.PersonalizedStemCells.com.