drugset / Trial / NCT03068988
Clinical Study on Mesenchymal Stem Cells Used in the Reconstruction Surgery of the Supraspinatus Muscle Lesions
RandomizedParallel-groupTriple-blindTreatment
Summary
The prospective randomized clinical study investigating the effect of mesenchymal stem cells on tendon healing. The objective of the study is to demonstrate the effect of concentrated bone marrow stem cells ( MSCs ) to the healing of sutured tendon of the supraspinatus muscle in comparison to the same procedure performed without MSCs. We have postulated the hypothesis that MSCs enhance the healing of the sutured supraspinatus tendon to its humeral footprint.
Timeline
- Start
- 2012-01-01
- Primary completion
- 2014-12-31
- Completion
- 2021-12-31
Publications
- Results Goutallier D, Postel JM, Bernageau J, Lavau L, Voisin MC. Fatty muscle degeneration in cuff ruptures. Pre- and postoperative evaluation by CT scan. Clin Orthop Relat Res. 1994 Jul;(304):78-83.
- Results Thomazeau H, Boukobza E, Morcet N, Chaperon J, Langlais F. Prediction of rotator cuff repair results by magnetic resonance imaging. Clin Orthop Relat Res. 1997 Nov;(344):275-83.
- Results Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 May;(254):81-6.
- Results Richards RR, An KN, Bigliani LU, Friedman RJ, Gartsman GM, Gristina AG, Iannotti JP, Mow VC, Sidles JA, Zuckerman JD. A standardized method for the assessment of shoulder function. J Shoulder Elbow Surg. 1994 Nov;3(6):347-52. doi: 10.1016/S1058-2746(09)80019-0. Epub 2009 Feb 13.
- Results Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mesenchymal stem cells | Cell therapy | — | Other |