Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears

Not Applicable

Withdrawn

• Conditions: Rotator Cuff Injury; Rotator Cuff Tear
• Interventions: Procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate; Procedure: Arthroscopic rotator cuff repair

• Registration Number: NCT03688308
• Lead Sponsor: Stanford University

Brief Summary

The primary objective is to determine whether adjunct treatment using bone marrow aspirate concentrate (BMAC) in conjunction with arthroscopic repair of rotator cuff tears reduces retear rates compared to a control population undergoing arthroscopic repair without BMAC administration. The secondary objectives are to (1) evaluate the survival and incorporation of BMAC labeled cells with MRI imaging using the Ferumoxytol infusion stem cell labeling technique, and (2) determine if administration of BMAC leads to better clinical outcomes as measured by ASES, UCLA and Constant scoring metrics.

Detailed Description

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 Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-28
• Study Start: 2020-01-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults aged 50-75 patients with MRI confirmed rotator cuff tears sized 1.5-3cm including supraspinatus with or without an associated partial infraspinatus or subscapularis tear
• Chronic tear > 3 months
• Failed a minimum of 6 weeks of physical therapy
• Hamada stage 1
• Goutallier staging < 3

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Exclusion Criteria

• Radiographs demonstrating mild to moderate arthritis
• Diagnosis of Inflammatory (RA, JIA etc) or infectious arthritis
• Hamada stage > 2
• Cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
• Brachial plexus pathology
• Currently pregnant or planning to become pregnant
• Shoulder PRP injection within the last year
• History of iron overload syndrome
• Concurrent surgery for shoulder instability

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shoulder arthroscopy with BMAC	Arthroscopic rotator cuff repair with bone marrow aspirate concentrate	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
Shoulder arthroscopy alone	Arthroscopic rotator cuff repair	This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair without administration of BMAC.

Primary Outcome Measures

Name	Time	Method
Tendon healing rates	24 months	Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery

Secondary Outcome Measures

Name	Time	Method
ASES Score	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.
UCLA Score	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.
Constant Score	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	7 days	Imaging of labeled mesenchymal stems cells in the shoulder to assess retention post injection

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States