Utilization of AMSC to Enhance Rotator Cuff Repair

Status Terminated

Clinical Trial Summary

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.

Clinical Trial Description

Eligible patients will undergo an arthroscopic rotator cuff repair augmented by mesenchymal stem cells (MSCs). The primary objective of the trial is to assess the safety and tolerability of autologous mesenchymal stem cells treatment applied during arthroscopic rotator cuff repair.

The condition of the patient will be monitored throughout the study. At each visit, adverse events (AEs) will be elicited using a standard non-leading questions. In addition, any signs or symptoms will be observed. All AEs will be collected as:

- patient's positive response to questions about their health

- symptoms spontaneously reported by the patient

- clinically relevant changes and abnormalities observed by the Investigator (e.g. local and systemic tolerability, clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations).

Clinical improvement will be measured by clinical outcome scores (Constant shoulder score and UCLA Shoulder rating scale) at 6 weeks, 6 months and 1 year after the surgery. MRI (Magnetic Resonance Imaging) findings made preoperatively and at 12 months (1 year) after operation will be evaluated.

During the indication visit, patient's history will be taken and preoperative MRI evaluated. Written consent form will be collected from the patient after detailed education of the patient by the investigator. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03838666
Study type	Interventional
Source	Bioinova, s.r.o.
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	December 12, 2012
Completion date	November 18, 2015

View Details

See also
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Withdrawn	`NCT03319784` - Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients	Phase 4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	`NCT01459536` - Assessment of Muscle Function and Size in Older Adults With Rotator Cuff Tear	N/A
Completed	`NCT01383239` - Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs	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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Utilization of AMSC to Enhance Rotator Cuff Repair - Safety and Efficacy — AMSC-RC-001

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms