First-in-human study to assess the safety and feasibility of intra-articular administration of allogeneic engineered gingival fibroblasts (aeGF) in participants with knee osteoarthritis.

2026-525604-99-00 Protocol GF-OA-001 Human pharmacology (Phase I) - First administration to humans Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol GF-OA-001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Authorised, recruitment pending
Participants planned 15
Countries 1
Sites 1

Knee osteoarthritis

Key facts

Sponsor
Scarcell Therapeutics
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Decision date (initial)
2026-05-26
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Knee osteoarthritis

VersionLevelCodeTermSystem organ class
21.1 LLT 10023476 Knee osteoarthritis 10028395

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Scarcell Therapeutics

Sponsor organisation
Scarcell Therapeutics
Address
101 Rue De Sevres
City
Paris
Postcode
75006
Country
France

Scientific contact point

Organisation
Scarcell Therapeutics
Contact name
Chief Medical Officer

Public contact point

Organisation
Scarcell Therapeutics
Contact name
Chief Executive Officer

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruitment pending 10 1
Rest of world
United Kingdom
5

Investigational sites

Denmark

1 site · Authorised, recruitment pending
Dantrials ApS
Department of Clinical Pharmacology, Nielsine Nielsens Vej 6b, 2400, Copenhagen Nv

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-03-20 Denmark Acceptable with conditions
2026-05-22
2026-05-26