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Tissue products

Decellularized tissue

Decellularized tissue is donor tissue processed to remove cellular material while preserving the structural matrix, including collagen, proteoglycans and related proteins, that the cells were embedded in.

Decellularization is a processing step, not a product category. Request the processing description and any residual-material testing tied to the specific lot rather than assuming a universal wash, digestion or extraction method, since these steps vary by manufacturer and are not standardized industry-wide.

Two products both labeled decellularized can still differ in composition. If this distinction is relevant to your evaluation, ask the supplier what was actually tested and documented for the lot in hand, rather than treating the word 'decellularized' as a specification in itself.

A clinic sourcing a decellularized allograft should ask for the processing description tied to the lot in hand, not a general product brochure. Relevant documents include a certificate of analysis, a donor eligibility summary and any composition or residual-material testing the supplier performed. Whether a specific intended use meets all applicable criteria in 21 CFR 1271.10 is a determination for the clinic and its counsel. These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.

Buyers need to know what 'decellularized' does and does not guarantee about a lot before relying on the label in purchasing or compliance decisions.

Sources

  1. 21 CFR 1271.10 - Are my HCT/Ps regulated solely under section 361 of the PHS Act ↗eCFR
  2. Umbilical cord-derived Wharton's jelly for regenerative medicine: a systematic review ↗PMC8618385