A Phase 2 interventional study of SclerFIX-IP in Osteoarthritis Hand, sponsored by TBF Genie Tissulaire. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of STT osteoarthritis.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 14 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated, devitalised and sterile graft of umbilical cord amniotic membrane
Biological: SclerFIX-IP
Decellularized, viro-inactivated, freeze-dried and sterile allogeneic graft of amniotic membrane of umbilical cord used as an interposition implant in the STT joint
Decrease of the symptomatology related to the STT OA
Quality of life related to STT OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit
Time frame: 12 months
Absence of inflammatory reactions and good local tolerance of the implant
No inflammatory reactions (oedema, erythema, necrosis, ulceration and/or delayed wound healing), no adverse effects or serious adverse effects.
Time frame: Through study completion (12 months)
Decrease of pain related to STT OA
Pain evaluated from 0 (no pain) to 10 (worst imaginable pain) on a visual analog scale (VAS)
Time frame: 1 month, 3 months, 6 months, 12 months
Improvement of functional activities involving the thumb
Functional activities involving the thumb evaluated from 0 (best) to 56 (worst) using the Buffet score developed by the Besançon University Hospital
Time frame: 1 month, 3 months, 6 months, 12 months
Increase of thumb strength
Thumb strength measured in kg by two-point pinch strength test using a pinch gauge
Time frame: 3 months, 6 months, 12 months
Increase of grip strength
Grip strength measured in kg by grip strength test using a dynamometer
Time frame: 3 months, 6 months, 12 months
No apparent joint space anomaly
Joint space evaluated on radiography using Crosby's classification
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.
Of 54 industry-sponsored phase 2 interventional studies under Osteoarthritis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's planned 30 months is above that.
Counting every sponsor, half of 82 studies reached it within 19 months; a quarter within 10 and three quarters within 38.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Dec 2026 → Nov 2026 and completion Dec 2026 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire