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NCT04077190
Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection Into Partial Thickness Rotator Cuff Tears
NA trial testing Adipose-derived stem cells in Rotator Cuff Tears in 15 participants. Completed in 1 December 2021.
1 November 2021
Quick facts
| Lead sponsor | InGeneron, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 August 2019 |
| Primary completion | 1 November 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Adipose-derived stem cells
- cortisone injection — full drug profile →
Conditions studied
- Rotator Cuff Tears — all drugs for Rotator Cuff Tears →
Sponsor
InGeneron, Inc. — full company profile →
Who can join
Adults 30 to 75, any sex, with Rotator Cuff Tears. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Extension Study of Protocol RC-001- Safety and Efficacy of Adult Adipose-Derived Stem Cell Injection into Partial Thickness Rotator Cuff Tears. Purpose is to investigate the Long- term safety and efficacy of autologous stem cells in patients with partial thickness rotator cuff tears versus a steroid treatment.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cell-Based Therapies for Rotator Cuff Injuries: An Updated Review of the Literature.
Hooper N, Marathe A, Jain NB, Jain NB, et al · · 2024 · cited 10× · PMID 38542113 · DOI 10.3390/ijms25063139 -
Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection of corticosteroid.
Lundeen M, Hurd JL, Hayes M, Hayes M, et al · · 2023 · cited 5× · PMID 37935850 · DOI 10.1038/s41598-023-46653-4 -
Epigenetic mechanisms in stem cell therapies for achilles tendinopathy.
Yuan Z, Yao Z, Mao X, Gao X, et al · · 2025 · PMID 40181824 · DOI 10.3389/fcell.2025.1516250 -
Long-term safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous, adipose-derived regenerative cells isolated at the point of care: 41 months follow-up of a prospective, randomized, controlled, first-in-hum
Lundeen M, Hurd JL, Hayes M, Hayes M, et al · · 2022 · DOI 10.1101/2022.12.14.22283447
Verify or expand the search:
- PubMed search for NCT04077190
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rotator Cuff Tears
Currently open trials in the same condition.
- NCT07383038 — Effect of Mobilization With Movement in Patients With Rotator Cuff Lesions · NA · recruiting
- NCT06918041 — FiberLocker® System Augmentation of Rotator Cuff Repairs · NA · recruiting
- NCT06886932 — Pain Education After Rotator Cuff Surgery · recruiting
- NCT07001566 — The Impact of Cervical Radiculopathy on Functionality in Patients Undergoing Rotator Cuff Repair · recruiting
- NCT06733480 — Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue · NA · recruiting
Other InGeneron, Inc. trials
Trials by the same sponsor.
- NCT05400798 — A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic P · NA · enrolling by invitation
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 NCT04077190 (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 InGeneron, Inc.
- Last refreshed: 3 August 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/NCT04077190.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing