Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 45 - 65 |
| Updated: | 1/16/2019 |
| Start Date: | March 1, 2019 |
| End Date: | December 31, 2021 |
| Contact: | Daniel Edon, MS, CSCS |
| Email: | EdonD@hss.edu |
| Phone: | 212-774-7833 |
A Phase II Study to Evaluate Autologous Stromal Vascular Fraction Cell Therapy to Improve the Repair of Chronically 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.
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.
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
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
We found this trial at
1
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Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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