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Rotator Cuff TearsNCT06361797

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

A study testing Rotator cuff repair augmented with whole bone marrow and Rotator cuff repair augmented with concentrated bone marrow in people with Rotator Cuff Tears, run by Johns Hopkins University at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Rotator Cuff Tears
What is being tested?
Rotator cuff repair augmented with whole bone marrow and Rotator cuff repair augmented with concentrated bone marrow
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
Feb 2025to Dec 2027
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 38Show fewer
  • 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.
  • Subjects with stiffness due to Adhesive Capsulitis.
  • An abnormality will be deemed clinically significant, based on clinical laboratory reference ranges and the investigator's clinical judgment, if either of the following are met at baseline:
  • The abnormality suggests a disease and/or organ toxicity.
  • The abnormality is of a degree that requires additional active management, such as close observation, change in medication, or further diagnostic investigation.
  • Intra-Operative Exclusion Criteria
  • Subjects who meet any of the following intra-operative criteria will be excluded from participating in this study:
  • Subject has a rotator cuff tear smaller than 1.0 cm or bigger than 4.0 cm.
  • Subject requires concurrent subscapularis or teres minor, labral repair, fracture repair or reconstruction.
  • Subject has a rotator cuff tear not amenable to TOE repair and/or arthroscopic repair.
  • Tear is not fully repairable.
  • Subject has advanced glenohumeral arthritis upon visual inspection.
  • Insufficient volume of bone marrow was aspirated for treatment arm.
  • If for any reason, obtaining bone marrow from the proximal humerus shaft is either impractical or harmful to the patient.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins Howard County General Hospital

    Columbia, Maryland, 21230

  • Johns Hopkins Medicine - Green Spring Station

    Lutherville, Maryland, 21093

Other trials in United States

About this study

Official title: Varying Bone Marrow-Derived Mesenchymal Stem Cell Concentrations' Impact on Rotator Cuff Repair Outcomes

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

Read the detailed description

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

The participants will be randomized intraoperatively after confirmation of inclusion criteria.

The participants will be followed-up at 2 weeks, 1 month, 3 months, 6 months, 12 months and 24 months post-operatively.

Primary outcome is re-tear of the rotator cuff demonstrated by 6-month post-operative MRI.

Additional outcomes include American Shoulder and Elbow Surgeons questionnaire (ASES), Visual Analogue Scale (VAS), Subjective Shoulder Value (SSV), and Comprehensive Shoulder Assessment (CSA).

The investigators will also assess the rate of revision surgery and required oral and intra-articular corticosteroids in each study arm.

A sample of bone marrow obtained intraoperatively will be analyzed to identify osteogenic progenitor cells.

Being tested
Rotator cuff repair augmented with whole bone marrow, Rotator cuff repair augmented with concentrated bone marrow
Keywords
rotator cuff tear, bone marrow aspirate, bone marrow, double-row transosseous technique
Medical subject headings
Rotator Cuff Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotator cuff repair augmented with whole bone marrowOther

    Also called Whole bone marrow, Bone marrow aspirate

    Bone marrow derived from the proximal humerus will be aspirated during the rotator cuff repair. At the end of the procedure, the aspirate will be injected back into the joint space.

  • Rotator cuff repair augmented with concentrated bone marrowOther

    Also called Bone marrow-derived mesenchymal stem cells, Bone marrow concentrate

    Bone marrow derived from the proximal humerus will be aspirated during the rotator cuff repair. This volume will be concentrated and, at the end of the procedure, the concentrate will be injected back into the joint space.

Study groups in NCT06361797
Study groupRoleWhat they receive
4cc bone marrow aspirateActive comparatorBone marrow aspirate, 4cc
Receives: Other: Rotator cuff repair augmented with whole bone marrow
20cc bone marrow aspirateExperimentalBone marrow aspirate, 20cc
Receives: Other: Rotator cuff repair augmented with whole bone marrow
Bone marrow concentrateExperimental20cc of whole bone marrow concentrated (varying quantities)
Receives: Other: Rotator cuff repair augmented with concentrated bone marrow

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Rotator cuff re-tears as assessed by magnetic resonance imaging

    Re-tear of the rotator cuff as determined by magnetic resonance imaging of the shoulder. Assessors will review blinded imaging to determine if there was a retear on MRI.

    Measured: 6 months post-operatively

Secondary outcomes (6)

  1. American Shoulder and Elbow Surgeons Score

    Score to determine shoulder condition and its impact on quality of life. Scored from 0 (worst) to 100 (best).

    Measured: Pre-surgery, 2 weeks post-surgery, 1 month post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 24 months post-surgery

  2. Visual Analogue Pain Score

    Standard pain scale. Scored from 0 (no pain) to 10 (worst pain possible).

    Measured: Pre-surgery, 2 weeks post-surgery, 1 month post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 24 months post-surgery

  3. Subjective Shoulder Value score

    Patient's evaluation of shoulder function. Scored from 0 (worst) to 100 (best).

    Measured: Pre-surgery, 2 weeks post-surgery, 1 month post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 24 months post-surgery

  4. Comprehensive Shoulder Assessment

    The Comprehensive Shoulder Assessment is a shoulder-specific quality of life score. Scored from 0 (worst) to 100 (best).

    Measured: Pre-surgery, 2 weeks post-surgery, 1 month post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 24 months post-surgery

  5. Revision surgery rate

    The rate of participants in each arm requiring revision surgery for any reason.

    Measured: Up to 2 years.

  6. Rate of oral and/or intra-articular corticosteroid required

    The rate of required oral and/or intra-articular corticosteroids in each study arm.

    Measured: Up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2024
  2. Study startFeb 2025 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Why it stopped: PI leaving the institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is designed as a parallel group 1:1:1 randomized controlled trial.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06361797
Sponsor's protocol ID
IRB00415412
Status last verified
Nov 2024
First submitted
8 Apr 2024
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mather RC 3rd, Koenig L, Acevedo D, Dall TM, Gallo P, Romeo A, Tongue J, Williams G Jr. The societal and economic value of rotator cuff repair. J Bone Joint Surg Am. 2013 Nov 20;95(22):1993-2000. doi: 10.2106/JBJS.L.01495.

    PubMed 24257656

  • Lawrence RL, Moutzouros V, Bey MJ. Asymptomatic Rotator Cuff Tears. JBJS Rev. 2019 Jun;7(6):e9. doi: 10.2106/JBJS.RVW.18.00149.

    PubMed 31246863

  • Mandaleson A. Re-tears after rotator cuff repair: Current concepts review. J Clin Orthop Trauma. 2021 May 21;19:168-174. doi: 10.1016/j.jcot.2021.05.019. eCollection 2021 Aug.

    PubMed 34123722

  • Narayanan G, Nair LS, Laurencin CT. Regenerative Engineering of the Rotator Cuff of the Shoulder. ACS Biomater Sci Eng. 2018 Mar 12;4(3):751-786. doi: 10.1021/acsbiomaterials.7b00631. Epub 2018 Feb 6.

    PubMed 33418763

  • Vavken P, Sadoghi P, Palmer M, Rosso C, Mueller AM, Szoelloesy G, Valderrabano V. Platelet-Rich Plasma Reduces Retear Rates After Arthroscopic Repair of Small- and Medium-Sized Rotator Cuff Tears but Is Not Cost-Effective. Am J Sports Med. 2015 Dec;43(12):3071-6. doi: 10.1177/0363546515572777. Epub 2015 Mar 12.

    PubMed 25767267

  • Wang HN, Rong X, Yang LM, Hua WZ, Ni GX. Advances in Stem Cell Therapies for Rotator Cuff Injuries. Front Bioeng Biotechnol. 2022 May 25;10:866195. doi: 10.3389/fbioe.2022.866195. eCollection 2022.

    PubMed 35694228

  • Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7.

    PubMed 24913770

  • Banwart JC, Asher MA, Hassanein RS. Iliac crest bone graft harvest donor site morbidity. A statistical evaluation. Spine (Phila Pa 1976). 1995 May 1;20(9):1055-60. doi: 10.1097/00007632-199505000-00012.

    PubMed 7631235

  • Beitzel K, McCarthy MB, Cote MP, Durant TJ, Chowaniec DM, Solovyova O, Russell RP, Arciero RA, Mazzocca AD. Comparison of mesenchymal stem cells (osteoprogenitors) harvested from proximal humerus and distal femur during arthroscopic surgery. Arthroscopy. 2013 Feb;29(2):301-8. doi: 10.1016/j.arthro.2012.08.021. Epub 2013 Jan 3.

    PubMed 23290182

  • You T, Wu S, Ou X, Liu Y, Wang X. A network meta-analysis of arthroscopic rotator cuff repair. BMC Surg. 2023 Jul 13;23(1):201. doi: 10.1186/s12893-023-02078-4.

    PubMed 37443010

Questions about this trial

What is this clinical trial studying?

A study testing Rotator cuff repair augmented with whole bone marrow and Rotator cuff repair augmented with concentrated bone marrow in people with Rotator Cuff Tears, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Rotator cuff re-tears as assessed by magnetic resonance imaging (time frame: 6 months post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06361797, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.

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