Varying Bone Marrow-Derived Mesenchymal Stem Cells Concentrations' Impact on Rotator Cuff Repair Outcomes

Withdrawn before enrolling · Not applicable

Conditions studied: Rotator Cuff Tears

In brief

Randomized controlled trial comparing benefits of varying amounts of proximal humerus-derived bone marrow aspirate and bone marrow concentrate in rotator cuff repair.

Key facts

Study ID

NCT06361797

Run by

Johns Hopkins University

People needed

0

Starts

2025-02-01

Expected to finish

2027-12-01

Last updated by the study team

2024-11-29

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject has a primary symptomatic fully repairable rotator cuff tear ranging between 1.0 to 4.0 cm involving the supraspinatus and/or infraspinatus that is amenable to a double-row transosseous equivalent (TOE) repair.
• Subject's rotator cuff tear must be repaired arthroscopically.
• Subject has failed at least 6 weeks of conservative management, from symptoms onset, of at least 2 conservative treatments including oral pain medications [including but not limited to non-narcotics, NSAIDs, acetaminophen as per labeling of the medications], chiropractic care, rest and structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of rotator cuff tear injuries; or demonstrates the presence of unacceptable progressive symptoms or signs of acute functional deficit or intractable pain for which conservative care as noted above is otherwise not indicated.
• Subject has full passive movement of the arm comparable to the normal unaffected shoulder.
• Subject agrees to not use any NSAIDs e.g., naproxen, high dose aspirin, ibuprofen, Meloxicam, Diclofenac, etc., and/or acetaminophen for 1 week (7 days) prior to baseline, 2 weeks (14 days) prior to surgery and for 6 weeks post-surgery with the exception of low dose aspirin. In addition, the subject must agree to not use these products within 5 days of each follow-up visit starting with the 3-month visit, so as not to introduce confounding factors for assessments.
• Subject is willing and able to return for protocol required follow-up visits.
• Subject is willing and able to voluntarily sign the Institutional Review Board (IRB) approved Informed Consent.
• All genders, races, and ethnicities will be included.

You may not qualify if…

• Subject has any of the following conditions in the index shoulder: loss of ligaments, known neuromuscular or neurovascular compromise, deltoid deficiency (defect, tear, palsy), Samilson-Prieto Grade > 2 for osteoarthritis of glenohumeral joint, subject has a Goutallier Grade ≥3 fatty infiltration, history within the past 5 years of anterior or posterior shoulder subluxation or dislocation as determined by history, examination or radiographic findings.
• Subject's condition is bilateral and rotator cuff repair is scheduled or is to be scheduled over the course of this study for the contralateral shoulder.
• Subject requires concurrent fracture repair or reconstruction of the index shoulder.
• Subject has any of the following conditions: thrombocytopenia, anemia, platelet dysfunction syndrome, hemodynamic instability or septicemia.
• Subject has had a recent fever or illness.
• Subject has prior rotator cuff tendon repair, or ≥2 prior corticosteroid injections in the index shoulder.
• Subject has an underlying metabolic bone disease (e.g., Paget's disease, fibrous dysplasia, osteoporosis).
• Subject is at a higher risk for post-surgical bleeding (e.g., bleeding disorders; taking anticoagulants except low dose aspirin) or post-surgical infection (e.g., taking immunosuppressants; has a severe infection or recent use of systemic steroids).
• Subject has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome.
• Subject has any disease, condition or surgery which in the opinion of the investigator might impair healing, such as an active malignancy, history of metastatic malignancy, inflammatory or auto-immune based joint disease.
• Subject has evidence of a systemic infection, infection of the index shoulder or infection of the shoulder joint or overlying tissue such as septic arthritis, overlying cellulitis, or adjacent osteomyelitis.
• Subject has history of peripheral or central vascular disease, renal dysfunction, liver disease, chronic obstructive pulmonary disease, uncontrolled asthma, coagulopathies, cancers aside from basal cell carcinomas, uncontrolled neurological conditions, ongoing HIV, hepatitis B or C, active tuberculosis, recurrent infections, uncontrolled cardiac arrhythmias, or mental/emotional disorders that are not well controlled.
• Subject has diagnosed musculoskeletal cancer, or any other diagnosed cancer not on long term remission (e.g., at least 5 years or negative biopsy at last exam) except basal cell carcinoma.
• Subject who demonstrates any clinically significant abnormality for any of the following hematology testing within 30 days (± 2days) of enrollment: complete blood count with differential, blood chemistry [comprehensive metabolic panel including aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), bilirubin, creatinine, and CRP), coagulation profile (including international normalized ration (INR), prothrombin time (PT), activated partial thromboplastin time (APTT)], Thrombin Time (TT) and, fibrinogen (FIB).
• Subject who demonstrates any clinically significant abnormality* for any of the following vital signs within 30 days (± 2days) of enrollment, systolic BP > 160 mmHg or < 90 mmHg, pulse > 100 bpm or < 60 bpm, Respiratory Rate > 25 or < 10, O2 saturation < 90% on Room Air.
• Subject with any mental or psychological disorder that would impair their decisional capability.
• Subject has uncontrolled, defined as Hemoglobin A1c of > 8.0%, or insulin-dependent diabetes.
• Subject with a documented history of substance abuse within six months of treatment.
• Subject has known claustrophobia and/or contraindications to MRI.
• Subjects with any clinically significant finding that, in the investigator's judgment, would place the subject at health risk, impact the study, or affect the completion of the study.
• Subject has any medical problem that precludes the subject from undergoing elective surgery.
• Subjects who are participating concurrently in another clinical study or have participated in a clinical study within 30 days of surgery (Day 0) or intend to during the course of the study.
• Subject is pregnant.
• Subject taking systemic steroids (excluding inhalers) and/or auto-immune suppressor drugs within 3 months prior to surgery (Day 0) or who are at risk of needing systemic steroids, such as for asthma.
• Subjects who are currently involved in any injury litigation relating to the index shoulder.

Where it is running

• Johns Hopkins Howard County General Hospital — Columbia, Maryland, United States
• Johns Hopkins Medicine - Green Spring Station — Lutherville, Maryland, United States

Full record on ClinicalTrials.gov

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