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Bone Marrow Derived Stem Cells for the Treatment of Rotator Cuff Tears
Not Recruiting
Trial ID: NCT03688308
Purpose
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.
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
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
Intervention(s):
procedure: Arthroscopic rotator cuff repair with bone marrow aspirate concentrate
procedure: Arthroscopic rotator cuff repair
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Anna Ramakrishnan
650-497-3597