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

Hospital for Special Surgery (HSS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Rotator Cuff Tear; Muscle Atrophy; Tendon Tear

Treatments: Device: Autologous Stomal Vascular Fraction Material; Device: Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03332238

2017-0999

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Device: Ringer's solution

Cell Therapy

Active Comparator group

Description:

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

Treatment:

Device: Autologous Stomal Vascular Fraction Material