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Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears (SVF)

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ClinicalTrials.gov Identifier: NCT05264922
Recruitment Status : Withdrawn (Reorganization of the department at the institution.)
First Posted : March 3, 2022
Last Update Posted : December 21, 2022
Sponsor:
Information provided by (Responsible Party):
AdventHealth

Brief Summary:
The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Drug: Tisseel Injectable Product Biological: Stromal Vascular Fraction Cells Phase 2

Detailed Description:

Small rotator cuff tendon tears are a hard task in shoulder care. They are often not operated on because research has not shown any increased benefit of surgery over physical therapy. The most common way to treat these tears is through physical therapy or steroid injections. However, the relief doesn't last very long. Recent studies have shown a lot of tears get worse over time. This happens because the physical therapy options can treat the pain and symptoms, but do not heal the actual tear.

Another non-surgical option for treating small tears is through adipose-derived stem cells. Adipose-derived stem cells are cells that are found in the fat in our bodies. The cells have shown promise in fixing tissues and may provide help to treat small rotator cuff tears. The investigators are studying a part of these fat cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. This is important because they may be able to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used these cells to help small tears without surgery. The use of SVF is investigational. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). The FDA is allowing the use of this drug for research. The investigators goal is to determine the effectiveness of SVF cell injection to treat small rotator cuff tears without surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized 1:1 to SVF Cells & Fibrin Glue or Fibrin Glue alone.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The provider (PI) and team performing the injection will not care for the subject during follow up.
Primary Purpose: Treatment
Official Title: Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears
Actual Study Start Date : January 10, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Fibrin Glue
Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution
Drug: Tisseel Injectable Product
Fibrin glue will provide an inert, biocompatible, viscous substance able to remain within the Rotator Cuff (RC) defect rather than injecting SVF cells in saline.
Other Name: Fibrin Glue

Experimental: SVF cells and Fibrin Glue
Nucleated adipose-derived cells loaded in a fibrin glue scaffold
Drug: Tisseel Injectable Product
Fibrin glue will provide an inert, biocompatible, viscous substance able to remain within the Rotator Cuff (RC) defect rather than injecting SVF cells in saline.
Other Name: Fibrin Glue

Biological: Stromal Vascular Fraction Cells
Stromal Vascular Fraction cells are autologously harvested, processed and reinjected into the affected shoulder.




Primary Outcome Measures :
  1. Primary Efficacy - MRI-measured healing rate in the rotator cuff tear [ Time Frame: 24 months ]
    Healing rates between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.

  2. Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint [ Time Frame: 24 months ]
    Both study-related AE assessments and the clinical record will be interrogated to determine if the subjects had any adverse events involving the affected joint. Incidence and rates of AEs between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.


Secondary Outcome Measures :
  1. Patient-reported measures Western Ontario Rotator Cuff (WORC) Index [ Time Frame: 24 months ]
    WORC score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. The investigators expect the SVF-treated patients to improve by over 12% on the WORC at the final 2-yr follow-up.

  2. Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 24 months ]
    PROMIS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP.expect the SVF-treated patients to improve by 10 points on the PROMIS at the final 2-yr follow-up.

  3. Patient-reported measures Visual Analog Scale (VAS) [ Time Frame: 24 months ]
    Pain VAS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. expect the SVF-treated patients to improve by over 12% on the WORC, by 10 points on the PROMIS, and by 20% on the pain VAS by the final 2-yr follow-up. expect the SVF-treated patients to improve by 20% on the pain VAS at the final 2-yr follow-up.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Male and female patients 30-65 years of age
  2. Symptomatic partial-thickness rotator cuff tears
  3. Suitable candidate for lipoaspiration and autologous adipose derived stem cell therapy as per physician.

Exclusion Criteria

  1. History of RC repair of affected shoulder, osteomyelitis or septic arthritis;
  2. Primary diagnosis of osteoarthritis, primary adhesive capsulitis;
  3. Full thickness rotator cuff tear
  4. RC tear of the subscapularis (SSc) or teres minor (TM), or a RC tear at the musculotendinous junction.
  5. Prescribed physical therapy or injection (of any nature) to shoulder prior to initial visit (within past 3 months);
  6. Clinically significant medical diseases that can impact tissue healing (i.e. Cardiovascular/peripheral vascular disease, diabetes, cancer, endocrine disease, hepatic disease (hepatitis), renal disease, autoimmune/inflammatory disease, HIV;
  7. Cervical spine radiculopathy;
  8. Current anticoagulation therapy (excluding Aspirin 81mg), immunosuppressant medication, narcotic use;
  9. Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraception for the first year of the study (i.e. oral contraceptive, barrier method, intrauterine device (IUD), intramuscular contraceptive);
  10. Subjects with abnormal hematology or serum chemistry lab results, outside of the normal range, as defined by the American Board of Internal Medicine (ABIM) Laboratory Test Reference Ranges, which are clinically significant, in the opinion of the investigator;
  11. BMI greater than 40 kg/m2;
  12. History of tobacco use within last 3 years;
  13. Subject has been diagnosed with any bleeding disorders, including but not limited to: hemophilia A or B, Von Willebrand Disease;
  14. Currently participating, or has participated in any other clinical trials within 6 months prior to the screening visit;
  15. Subjects has any significant medical condition, that in the option of the investigator, would make them unable to provide informed consent and/or interfere with their compliance of study requirements;
  16. Subject has a documented allergy to the anesthetic or any component of the injectable, including but not limited to: aprotinin.
  17. Subject has a contraindication for completing the MRI (i.e. pacemaker, aneurysm clip, metal fragments, etc that may become dislodged) or has problems with loud noises or claustrophobia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05264922


Locations
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United States, Florida
AdventHealth Orlando
Orlando, Florida, United States, 32803
Sponsors and Collaborators
AdventHealth
Investigators
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Principal Investigator: Tariq Awan, DO AdventHealth Orlando
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Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT05264922    
Other Study ID Numbers: 1719310
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: December 21, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Fibrin Tissue Adhesive
Hemostatics
Coagulants