Rotator Cuff Tear Clinical Trial
Official title:
Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Tendon Disease: a Randomized Controlled Trial
This study was a single-center, randomized, single-blind clinical trial. We plan to include 100 patients who met exclusion criteria of rotator cuff and lateral epicondylosis (tennis elbow) respectively by MRT or ultrasonography. The patients will be randomly divided into two groups. Adipose mesenchymal stem cells will be isolated from adipose tissue, cultured and then transplanted back to the tendon injury site by multiple point injection. 1*10^6 cells as an unit. Patients in the experiment group will be injected into an unit of adipose mesenchymal stem cells (1*10^6/10kg) while the control group received the same dose compound betamethasone injection. Follow up visit for all patients will occur at 1，3，6 and 12 months after the first injection. Clinical quantitative assessment will measure by the visual analogue scale(VAS). The secondary outcomes are the constant-murley score(CMS) and the rating scale of the American shoulder and elbow surgeons(ASES) and the disability of arm shoulder and hand(DASH). The objective evaluation methods is that the examination of MRI or ultrasound were accomplished before the first injection and at 6 and 12 months afterwards.
All injection will be done under ultrasound guidance. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03663036 -
Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis
|
N/A | |
| Suspended |
NCT03290196 -
The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
|
Phase 4 | |
| Active, not recruiting |
NCT03091075 -
Oxandrolone Rotator Cuff Trial
|
N/A | |
| Completed |
NCT03380533 -
Buprenorphine Transdermal Patches in Arthroscopic Rotator Cuff Repair
|
Phase 2/Phase 3 | |
| Completed |
NCT04566939 -
A Long Term Follow-Up of Rotator Cuff Tear Patients Treated With Integrated Complementary and Alternative Medicine
|
||
| Active, not recruiting |
NCT02716441 -
Rotator Cuff Failure With Continuity
|
||
| Completed |
NCT03540030 -
Opioid-Free Shoulder Arthroplasty
|
Phase 4 | |
| Completed |
NCT02298023 -
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
|
Phase 2 | |
| Completed |
NCT01383239 -
Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
|
N/A | |
| Completed |
NCT01459536 -
Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear
|
N/A | |
| Completed |
NCT02850211 -
A Selective COX-2 Inhibitor Provides Pain Control But Hinders Healing Following Arthroscopic Rotator Cuff Repair
|
Phase 4 | |
| Completed |
NCT01204606 -
Arthroscopic Rotator Cuff Repair With Multimodal Analgesia(MMA)
|
N/A | |
| Terminated |
NCT00936559 -
Study Evaluating Safety Of BMP-655/ACS As An Adjuvant Therapy For Rotator Cuff Repair
|
Phase 1 | |
| Completed |
NCT01170312 -
Arthroscopic Surgery and Platelet Rich Plasma In Rotator Cuff Tear Evaluation
|
N/A | |
| Completed |
NCT00852657 -
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff
|
N/A | |
| Active, not recruiting |
NCT00182299 -
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
|
Phase 4 | |
| Recruiting |
NCT06120998 -
Quality of Life After Arthroscopic Rotator Cuff Repair
|
||
| Completed |
NCT05897866 -
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
|
N/A | |
| Completed |
NCT02644564 -
Early Clinical Examination and Ultrasonography Screening of Acute Soft Tissue Shoulder Injuries
|
N/A |