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

• ClinicalTrials.gov Identifier: NCT03688308
• Recruitment Status: Recruiting
• First Posted: September 28, 2018
• Last Update Posted: March 29, 2019
• Sponsor: Stanford University
• Information provided by (Responsible Party): Jason L. Dragoo, Stanford University

Tracking Information

• First Submitted Date: September 21, 2018
• First Posted Date: September 28, 2018
• Last Update Posted Date: March 29, 2019
• Actual Study Start Date: March 27, 2019
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2018)

Tendon healing rates [ Time Frame: 24 months ]

Percent of rotator cuff repairs that demonstrate full healing at 2 years post surgery

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 26, 2018)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears
• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
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

Primary Purpose: Treatment

Condition

• Rotator Cuff Tear
• Rotator Cuff Injury

Intervention

• 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)
• Procedure: Arthroscopic rotator cuff repair
  Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 26, 2018): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 2021
• Estimated Primary Completion Date: October 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Anna Ramakrishnan; (650) 497-3597; annarama@stanford.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03688308
• Other Study ID Numbers: IRB-47762
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Jason L. Dragoo, Stanford University
• Study Sponsor: Stanford University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jason L Dragoo; Stanford University

• PRS Account: Stanford University
• Verification Date: March 2019