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NCT Number: NCT03332238

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rotator Cuff Tear Atrophy Muscle Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rotator Cuff Injuries Rupture Shoulder Injuries Signs and Symptoms Tendon Injuries Tendon Tear Wounds and Injuries

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Stomal Vascular Fraction Material

Device

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

Ringer's solution

Device

Ringer's solution

Primary outcomes

  1. Change in scapular plane abduction strength from baseline, and additional isometric, isokinetic strength measurements to assess supraspinatus function.

    Time frame: 2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery

Secondary outcomes

  1. Change in Penn Shoulder score, ASES score and Short Form Global Health scale (PROMIS-SF) from baseline (range 0 minimum to 30 maximum)

    Time frame: 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery

  2. Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography

    Time frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery

  3. Change in fatty infiltration from baseline, measured by magnetic resonance imaging

    Time frame: 1 month prior to surgery, 6 months after surgery, 24 months after surgery

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Orthopedic Research and Education Foundation

Registry information

Official study title

A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically Rotator Cuff Tears

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Nov 6, 2017
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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