Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears
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|ClinicalTrials.gov Identifier: NCT03688308|
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rotator Cuff Tear Rotator Cuff Injury||Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate Procedure: Arthroscopic rotator cuff repair||Not Applicable|
Rotator cuff repair and regeneration has become a focal point for scientists and surgeons in search for a biological treatment to improve tendon healing, especially in situations of unfavorable biological conditions. Recent literature supports harvesting and centrifuging bone marrow aspirate to produce bone marrow aspirate concentration (BMAC) in hopes that mesenchymal stem cells in the bone marrow aspirate can promote tendon healing and regeneration.
This is a single blinded randomized clinical trial using labeled BMAC cells in adults diagnosed with medium to large, single tears of the rotator cuff. This is a single site study where at least 45 cases among eligible patients will be identified and randomly assigned to a either a control (arthroscopic repair without BMAC) group or experimental (arthroscopic repair with BMAC) group. A power analysis will be performed after enrolling 20 patients to determine the total number of patients required to reach adequate power.
A patient will receive an infusion of Ferumoxytol 1 day prior to the surgical procedure. An infusion nurse will be present at all times during the infusion to monitor vitals. On the day of the surgical procedure patients in the both groups will undergo arthroscopic rotator cuff repair using a double-row technique. Patients in the experimental group will also undergo harvesting of bone marrow aspirate from the anterior inferior iliac crest, which will be centrifuged to about 3-4cc of BMAC and placed beneath the tendon at the bone interface. MRIs will be completed on days 1 and 7 post-operatively to track retention of the labeled mesenchymal cells. Ultrasound imaging will be performed at 6 months post-surgery to evaluate tendon healing. Final MRIs will be obtained at 1 year and 2 years post surgery. Patient related outcomes will be collected at the pre-operative visit, 3 months, 6 months, 1 year and 2 years post surgery in the forms of ASES, UCLA and Constant scoring.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Patients will not know if they received the surgical intervention that includes BMAC administration|
|Official Title:||Randomized Control Trial of Bone Marrow Derived Stem Cells Combined With Arthroscopic Surgery Versus Arthroscopic Surgery Only for the Treatment of Rotator Cuff Tears|
|Actual Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
Experimental: Shoulder arthroscopy with BMAC
This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair along with 3-4cc of BMAC produced from the Harvest/Terumo BCT system
Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate
Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique. Subjects will also be injected with bone marrow aspirate concentrate harvested from the pelvis and centrifuged prior to injection in the shoulder (produced using the Harvest/Terumo BCT system)
Other Name: Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)
Active Comparator: Shoulder arthroscopy alone
This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair without administration of BMAC.
Procedure: Arthroscopic rotator cuff repair
Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.
- Tendon healing rates [ Time Frame: 24 months ]Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery
- UCLA Score [ Time Frame: Date of enrollment to 24 months post-operatively ]UCLA score (0-35 points; higher score is better) at 24 months post surgery to measure functional outcome.
- ASES Score [ Time Frame: Date of enrollment to 24 months post-operatively ]American Shoulder and Elbow Surgeons Shoulder Score (ASES) (0-100 points; higher score is better) at 24 months to measure functional outcome.
- Constant Score [ Time Frame: Date of enrollment to 24 months post-operatively ]Constant score (0-100 points; higher score is better) at 24 months.
- Retention of the mesenchymal stem cells [ Time Frame: 7 days ]Imaging of labeled mesenchymal stems cells in the shoulder to assess retention post injection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688308
|Contact: Anna Ramakrishnan||(650) firstname.lastname@example.org|
|United States, California|
|Redwood City, California, United States, 94063|
|Contact: Anna Ramakrishnan 650-497-3597 email@example.com|
|Principal Investigator:||Jason L Dragoo||Stanford University|