Last reviewed · How we verify
NCT01020825: LTE
A Prospective Study for the Assessment of the Long-term Safety and Efficacy of Cx401 in Patients Taking Part in the FATT-1 Trial
trial testing ASCs in Complex Perianal Fistula in 148 participants. Completed in 1 May 2010.
1 March 2010
Quick facts
| Lead sponsor | Tigenix S.A.U. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 148 |
| Start date | 1 September 2008 |
| Primary completion | 1 March 2010 |
| Estimated completion | 1 May 2010 |
| Sites | 15 locations across Spain |
Drugs / interventions tested
- ASCs — full drug profile →
- Fibrin glue — full drug profile →
- ASCs — full drug profile →
Conditions studied
- Complex Perianal Fistula — all drugs for Complex Perianal Fistula →
Sponsor
Tigenix S.A.U. — full company profile →
Who can join
18 and older, any sex, with Complex Perianal Fistula. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cumulative incidence of adverse events (clinical or laboratory) attributed to the study therapy in the preceding FATT-1 randomized trial (CX401 or fibrin glue)
Time frame: 6 months (since last visit in FATT-1 trial)
Sponsor's own description
The purpose of this extension is to investigate and confirm the long-term (6 months) safety and efficacy of the preceding FATT-1 trial \[ClinicalTrials.gov identifier: NTC00475410\], which studied patients with perianal fistula treated having received adipose-derived adult stem cell (ASC)and/or fibrin glue.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Adipose-Derived Stem Cells for Tissue Engineering and Regenerative Medicine Applications.
Dai R, Wang Z, Samanipour R, Koo KI, et al · · 2016 · cited 191× · PMID 27057174 · DOI 10.1155/2016/6737345 -
Adipose-derived stromal cells: Their identity and uses in clinical trials, an update.
Casteilla L, Planat-Benard V, Laharrague P, Cousin B. · · 2011 · cited 162× · PMID 21607134 · DOI 10.4252/wjsc.v3.i4.25 -
The Use of Adipose-Derived Stem Cells in Selected Skin Diseases (Vitiligo, Alopecia, and Nonhealing Wounds).
Owczarczyk-Saczonek A, Wociór A, Placek W, Maksymowicz W, et al · · 2017 · cited 22× · PMID 28904532 · DOI 10.1155/2017/4740709
Verify or expand the search:
- PubMed search for NCT01020825
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ASCs
Trials testing the same drug.
- NCT04615455 — Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome · Phase 2 · completed
Other recruiting trials for Complex Perianal Fistula
Currently open trials in the same condition.
- NCT04940611 — A Study of Surgical Interventions in Fistulizing Conditions · active not recruiting
Other Tigenix S.A.U. trials
Trials by the same sponsor.
- NCT03279081 — Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatm · Phase 3 · completed
- NCT03158727 — Cx611-0204 SEPCELL Study · Phase 1, PHASE2 · completed
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 NCT01020825 (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 Tigenix S.A.U.
- Last refreshed: 10 April 2019
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/NCT01020825.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing