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

NCT ID: NCT03688308

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-10-31

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.

Conditions

Rotator Cuff Tear; Rotator Cuff Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Arthroscopic rotator cuff repair with bone marrow aspirate concentrate

Intervention Type: PROCEDURE

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)

Shoulder arthroscopy alone

This arm will have patients who receive surgical intervention with arthroscopic rotator cuff repair without administration of BMAC.

Group Type: ACTIVE_COMPARATOR

Arthroscopic rotator cuff repair

Intervention Type: PROCEDURE

Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.

Interventions

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)

Intervention Type: PROCEDURE

Arthroscopic rotator cuff repair

Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.

Intervention Type: PROCEDURE

Other Intervention Names

Injection of bone marrow aspirate concentrate harvested from the patient's iliac crest (produced using the Harvest/Terumo BCT system)

Eligibility Criteria

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

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason L Dragoo

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Redwood City, California, United States

Countries

United States

Other Identifiers

IRB-47762

Identifier Type: -

Identifier Source: org_study_id