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NCT02896387: PRIMAculture
Ability of a Molecule (Prima) to Restore Physiological Differentiation in Epithelium Expressing Gene p63
trial in Ectodermal Dysplasia in 5 participants. Terminated before completion.
1 January 2022
Quick facts
| Lead sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 5 |
| Start date | 3 March 2017 |
| Primary completion | 1 January 2022 |
| Estimated completion | 1 January 2022 |
| Sites | 2 locations across France |
Conditions studied
- Ectodermal Dysplasia — all drugs for Ectodermal Dysplasia →
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild — full company profile →
Who can join
7 and older, any sex, with Ectodermal Dysplasia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Ectodermal dysplasia associated with p63 is a rare disease which, in addition to limbic abnormalities, primarily affects the skin and cornea. The most common forms are called Ectrodactyly, Ectodermal dysplasia, palate Key for cleft lip and palate (EEC) and Ankyloblepharon, Ectodermal dysplasia, cleft lip and palate (AEC). Apart from symptomatic treatment, no cure is available. To understand the molecular defects associated with this disease and to identify therapeutic tools, a research team modelized the disease by reprograming EEC and AEC patient fibroblasts in pluripotent stem cells (iPSC), then induced iPSC differentiation in patients and controls epidermal (skin) and limbic (cornea) cells and demonstrated that the mutated cells can reproduce in vitro the abnormalities observed in patients. P63 gene belongs to the family of p53 gene. The functions of the two proteins are very similar. Data suggest that molecule Prima could reactivate the p63 protein mutated in patients and thus alleviate skin defect healing and limbic regeneration.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Ethical and Safety Issues of Stem Cell-Based Therapy.
Volarevic V, Markovic BS, Gazdic M, Volarevic A, et al · · 2018 · cited 552× · PMID 29333086 · DOI 10.7150/ijms.21666
Verify or expand the search:
- PubMed search for NCT02896387
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
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Other Fondation Ophtalmologique Adolphe de Rothschild trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02896387 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondation Ophtalmologique Adolphe de Rothschild
- Last refreshed: 3 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02896387.
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