The words, defined.

Regenerative wellness

The umbrella term for an area of active scientific study that explores how the body’s own structural-support and repair systems work, and how carefully sourced human tissue products relate to them. It is a field of research, not a single treatment.

OsteoarthritisOA

The gradual wearing of the cartilage that cushions a joint. As cartilage thins, the joint moves less smoothly, which can cause pain, stiffness, and reduced range of motion. One of the most common causes of joint pain in adults over 50.

HCT/P

Human Cells, Tissues, and cellular and tissue-based Products. The FDA’s category for products made from human tissue. How an HCT/P is regulated depends on how it is processed and used.

Section 361 · 21 CFR Part 1271

The part of federal regulation covering tissue products that are minimally manipulated and used for a similar basic function as the original tissue. These products do not go through FDA pre-market approval, but the facilities that make them must meet donor-screening, processing, and labeling standards. Registered and inspected is not the same as approved.

Allograft

Tissue donated by one person for use in another (as opposed to autologous, which comes from your own body). Human tissue allografts used in this field are screened and processed by a laboratory.

Autologous vs. allogeneic

Autologous means from your own body — for example, platelet-rich plasma drawn from your own blood. Allogeneic means from a donor. The distinction affects how a product is regulated and what questions are worth asking.

Amniotic tissue

Allograft material derived from the amniotic membrane or fluid — the tissue that surrounds a developing baby, donated after a healthy, screened delivery. Regulated as a Section 361 tissue product when it meets the criteria.

Wharton’s jelly

A gelatinous tissue from the umbilical cord, donated after a healthy, screened delivery. Contains structural proteins and signaling molecules; studied as an allograft material and regulated under the same Section 361 framework.

Platelet-rich plasmaPRP

A preparation made by concentrating the platelets from a sample of a person’s own blood. Because it is autologous, it carries less regulatory complexity, and it has the most published clinical research among regenerative approaches.

Bone marrow aspirate concentrateBMAC

A concentrated preparation drawn from a person’s own bone marrow. Also autologous; used in some regenerative protocols and studied for musculoskeletal conditions.

Minimally manipulated

Processing that does not alter the original, relevant characteristics of the tissue. It is one of the criteria that determines whether a product is regulated under Section 361.

Homologous use

Using a tissue product for the same basic function it served in the donor. Another of the Section 361 criteria.

Certificate of AnalysisCoA

A document that records what a specific lot of a tissue product was tested for and released to. If a provider can’t produce one, they can’t actually tell you what you’d be receiving.

Donor screening

The required process of evaluating and testing a tissue donor for communicable disease and eligibility before any material is released — part of the standards a Section 361 facility must meet.

NAT testingNucleic Acid Testing

A sensitive method of testing donor material for specific pathogens by detecting their genetic material — one element of tissue screening and safety.

FDA-registered vs. FDA-approved

FDA-registered means a facility is registered with the FDA and subject to inspection. FDA-approved means the FDA has reviewed and approved a specific product to treat a specific condition. No regenerative tissue product in this category is FDA-approved to treat osteoarthritis or any disease — and confusing these two terms is the single most common way this category is misrepresented.

Management services organizationMSO

A company that provides education, standards, and business support so that independently licensed providers can focus on clinical care. Renvi Health is an MSO; it does not provide medical care itself.

Information on this page is educational and is not medical advice. Tissue products are regulated as Section 361 HCT/Ps under 21 CFR Part 1271 and are not approved by the U.S. Food and Drug Administration to diagnose, treat, cure, or prevent any disease. All decisions should be made with a licensed medical provider.