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Ongoing JCA

Autologous bioengineered skin substitute: EU joint clinical assessment

Treatment of adults and children with partial deep dermal and full-thickness burns

  1. Regulatory review
  2. CHMP opinion
  3. EU authorised
  4. JCA report published

Overview

Therapy area
Dermatology & wounds · Burns
Indication
Treatment of adults and children with partial deep dermal and full-thickness burns
Product type
ATMP, Orphan designation
EMA validation
16 Jul 2026
JCA assessor
HAS, France
Co-assessor
INAMI-RIZIV, Belgium
Regulatory status
Under EMA review. Matches the EU orphan-designated collagen hydrogel skin graft of autologous keratinocytes and fibroblasts studied as denovoSkin.
Pivotal evidence
Phase IIb intra-patient randomised (NCT03227146), n=14 (RCT (intra-patient))
01

Scope

The PICO forecast

JCA Pulse forecasts 1–2 PICOs for Autologous bioengineered skin substitute, with 2 candidate comparators. See the populations, comparators and likely outcomes the assessment is set to cover.

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02

Evidence

Fit against the likely scope

Autologous bioengineered skin substitute’s pivotal evidence (Phase IIb intra-patient randomised) is randomised. Pro scores how well it fits each likely PICO and flags where assessors may push back.

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03

Comparisons

Trials and indirect comparisons

Pro maps every trial likely in the Autologous bioengineered skin substitute dossier and projects the indirect comparison each comparator will need.

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04

Countries

National translator and outlook

France and Belgium lead the joint assessment. Pro explains what the JCA means for the national route in each of 31 markets.

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Sources

Last checked 5 November 2026. Compiled from public sources; check them for the latest position. Forecasts are Evidaxia’s independent view, not official assessments.

From Evidaxia