hADM (Human acellular dermal matrix)
This document is technical information about materials. It does not recommend any procedure or product.
In brief
Donated human dermis processed to remove cells while retaining the extracellular matrix. Unlike the synthetic polymers on this site it supplies matrix rather than provoking the host to build it, and it sits in a different regulatory lane.
Regulatory identity by market
COS cosmetic · MD medical device · RX drug · — not established in public sources
Identity & physical properties
| Synonyms | Human acellular dermal matrix, hADM, Acellular dermal matrix, ADM, Micronized acellular dermal matrix |
|---|---|
| Family | ECM-derived scaffold — decellularised human dermis |
| Particle size | Injectable forms are described as micronised or particulate; particle dimensions are not consistently reported between products |
| Morphology | Supplied as a sheet, or for injection as micronised or particulate matrix suspended in a carrier |
Mechanism
The literature describes a decellularised collagen scaffold that supports host cell repopulation and constructive remodelling of the dermis. This is presented as distinct from the foreign-body reaction that synthetic particulate materials rely on, though both routes end in matrix deposition.
Evidence
| PMID | Study type | Summary |
|---|---|---|
| 41381953 | RCT | Double-blind multicentre randomised equivalence trial of micronised acellular dermal matrix injection for nasolabial folds |
| 41828422 | RCT | Randomised split-face double-blinded trial of an injectable particulate hADM booster for skin restoration |
| 37069348 | in vivo | Comparison of biocompatibility and long-term structural integrity of injectable versus sheet-type hADM in mice |
| 36359387 | review | Review of human acellular dermal matrix in reconstructive surgery |
Regulatory identity — detail
| Market | Classification | Note | Basis |
|---|---|---|---|
| KR | unclassified | Donor-derived human tissue is handled under the Act on Safety and Management of Human Tissue, a pathway separate from the cosmetic, device and drug classifications used elsewhere in this table. The lane differs in kind, not in tier, so none of the three labels applies. | Legal text |
| EU | unclassified | Not established from public sources as of the revision date below. | — |
| US | unclassified | Human cells, tissues, and cellular and tissue-based products are regulated under 21 CFR Part 1271, again a separate pathway from the device and drug classifications used elsewhere in this table. | Legal text |
| JP | unclassified | Not established from public sources as of the revision date below. | — |
| CN | unclassified | Not established from public sources as of the revision date below. | — |
| VN | unclassified | Not established from public sources as of the revision date below. | — |
Limitations & open questions
Being donor-derived, donor screening and lot-to-lot variability form part of the risk profile in a way that does not arise for synthetic polymers. Decellularisation and sterilisation methods differ between manufacturers and are not standardised in the literature, so findings from one product do not transfer to another. Much of the published evidence concerns sheet forms in reconstructive surgery; the injectable literature is recent and smaller.
All statements on this page are drawn from the cited literature. Where a market’s regulatory classification could not be established from public sources, it is marked as not established rather than inferred.
This page is the clearest case for why the regulatory column on this site exists. The synthetic polyesters elsewhere in this atlas are classified as devices in several markets. hADM is not a device, a cosmetic or a drug in the markets where its pathway could be traced — it is donated tissue, governed by tissue legislation. Two materials aimed at the same layer of skin can therefore sit in entirely different bodies of law.