Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

NCT ID: NCT03332238

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2026-07-23

Brief Summary

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.

Conditions

Rotator Cuff Tear; Muscle Atrophy; Tendon Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cell Therapy

Patients will receive an injection of stromal vascular fraction material suspended in vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair

Group Type: ACTIVE_COMPARATOR

Autologous Stomal Vascular Fraction Material

Intervention Type: DEVICE

Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™

Placebo

Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair

Group Type: PLACEBO_COMPARATOR

Ringer's solution

Intervention Type: DEVICE

Ringer's solution

Interventions

Autologous Stomal Vascular Fraction Material

Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™

Intervention Type: DEVICE

Ringer's solution

Ringer's solution

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Males and females
• Age 45-65 years old at the time of enrollment
• Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm
• Magnetic resonance imaging Goutallier score ≤ grade 2
• Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy)
• Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate
• Must pass standard of care blood work screening

Exclusion Criteria

• Any tears of any cuff tendon other than the supraspinatus
• Magnetic resonance imaging Goutallier scores ≥ 3
• Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging
• A history of previous rotator cuff repair
• A history of upper extremity fracture or other moderate to severe upper extremity trauma
• A BMI < 20 or > 35
• Pregnant or breast feeding
• Premenopausal women who are not using contraception
• Previous abdominal liposuction or any major open abdominal surgery
• Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values > 6.5 or other metabolic disorders
• Hypercholesterolemia (total cholesterol ≥240mg/dL)
• History of cancer
• Autoimmune disorder or HIV+ status
• Use of nicotine products
• Have any other history of major medical illness, disease or other relevant orthopaedic disability
• Who do not speak English
• Liodcaine allergy

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopedic Research and Education Foundation

OTHER

Sponsor Role: collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Rodeo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Other Identifiers

2017-0999

Identifier Type: -

Identifier Source: org_study_id