Last reviewed · How we verify
NCT03838666: AMSC-RC-001
Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy
Phase 1, PHASE2 trial testing Suspension of human autologous MSC 3P in Rotator Cuff Tear in 9 participants. Terminated before completion.
18 November 2015
Quick facts
| Lead sponsor | Bioinova, s.r.o. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 12 December 2012 |
| Primary completion | 18 November 2015 |
| Estimated completion | 18 November 2015 |
Drugs / interventions tested
- Suspension of human autologous MSC 3P — full drug profile →
Conditions studied
- Rotator Cuff Tear — all drugs for Rotator Cuff Tear →
Sponsor
Bioinova, s.r.o. — full company profile →
Who can join
Adults 40 to 65, any sex, with Rotator Cuff Tear. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Subjects received perioperative hAMSC treatment in order to accelerate the healing of the surgically repaired rotator cuff and increase the mechanical properties of the tendon, according to inclusion and exclusion criteria (see below). Each patient will undergo post-operative follow-up at 6 weeks, 6 months and 12 months after the surgery. This will include a visual analogue score for pain (VAS), a questionnaire for the subjective Constant shoulder score, and the subjective questions of the University of California (UCLA) score. Preoperative and postoperative MRI at 12 months will be done to evaluate the quality of the rotator cuff repair.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03838666
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rotator Cuff Tear
Currently open trials in the same condition.
- NCT07412184 — Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff · NA · recruiting
- NCT06918041 — FiberLocker® System Augmentation of Rotator Cuff Repairs · NA · recruiting
- NCT07005063 — Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation · NA · recruiting
- NCT06878391 — ISB With SSNB & ANB · NA · recruiting
- NCT06766630 — Exploring the Feasibility of Silk Fibroin Surgical Mesh in Rotator Cuff Tears Repair Enhancement · Phase 2, PHASE3 · recruiting
Other Bioinova, s.r.o. trials
Trials by the same sponsor.
- NCT03827096 — Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease · Phase 1, PHASE2 · terminated
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 NCT03838666 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bioinova, s.r.o.
- Last refreshed: 15 February 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/NCT03838666.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing