Education and Training
Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate
- procedure: Arthroscopic rotator cuff repair
Eligibility
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
Ages Eligible for Study
50 Years - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Anna Ramakrishnan
650-497-3597
Not Recruiting