Compliance

FDA Regulations For Human Cellular & Tissue-Based Products.

 

The FDA regulates tissue transplant products including stem cells and maintains rigorous industry standards to maximize patient safety. Cellular and tissue products are not classified as drugs by the FDA when they adhere to FDA-defined criteria; rather, they are classified as HCT/P 361 products. Though these products are FDA regulated, they are not FDA approved. Therefore, when seeking cellular and tissue products, it is extremely important to find a company that has a clear and public record of interaction with the FDA.

The FDA has acknowledged that stem cell products have the potential to treat many medical conditions and diseases and have strict regulatory restrictions in place. The FDA routinely reviews manufacturers’ processes and procedures for compliance. As part of the FDA review, investigators must show how each product will be manufactured so the FDA can confirm appropriate steps are being taken to help assure the product’s safety, purity, and efficacy.

Homologous Use

Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) are defined in 21 CFR 1271.3(d) as articles containing or consisting of human cells or tissues that are intended for transplantation, infusion or transfer into a human recipient to assist in the body’s natural regenerative functions.

 

These products are cells / nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions.

 

These products are intended for homologous use, on a single patient, one time use only. They are used by licensed medical professionals (e.g., physician) on patients.

 

Minimal Manipulation

Compliance Rationale

Based on an evaluation of FDA regulations, FDA Guidance Documents (e.g., Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use, November 2017, and Tissue Reference Group (TRG) documents, Cellulam Core’s products are minimally manipulated and align to the regulatory factors in the table below.

Stem Cells are…

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Cells or nonstructural tissues that serve predominantly metabolic or other biochemical roles in the body such as hematopoietic, immune and endocrine functions
 (FDA Guidance Document – Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use).


Intended for homologous use to supplement the recipient’s tissue and assist in the body’s natural regenerative functions (Reference instructions for use).

Intended for homologous use only, as reflected by the labeling, advertising or other indications of the manufacturer’s objective intent (21 CFR 1271.10(a)(2)).

Minimally manipulated via processing procedures that include separation, cutting, grinding and shaping (FDA Guidance Document – Regulatory Considerations for Human Cell

Stem Cells are not…

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Processed in any way that alters relevant biological characteristics of cells or nonstructural tissues (21 CFR 1271.3(f)(2))

Manufactured in any way that involves the combination of cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or a sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P (21 CFR 1271.10(a)(3).

Dependent on having a systemic effect upon the metabolic activity of living cells for its primary function (21 CFR 1271.10(a)(4)(i)).

Incubated in a laboratory vessel where the processing affects the production of intracellular or cell-surface proteins or other markers of cell lineage, activation state and proliferation, thereby altering the cells’ biological characteristics of multipotency and capacity for self-renewal
(FDA Guidance Document – Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use).