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

NCT03332238 | Active Not Recruiting Phase 2 FDA Device

• 1 other identifier: 2017-0999
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  2 weeks prior to surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery

Secondary Outcomes (3)

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

  2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery

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

  1 month prior to surgery, 6 months after surgery, 24 months after surgery

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

  1 month prior to surgery, 6 months after surgery, 24 months after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Device: Ringer's solution

Cell Therapy

ACTIVE COMPARATOR

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

Device: Autologous Stomal Vascular Fraction Material

Interventions

Autologous Stomal Vascular Fraction Material DEVICE

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

Cell Therapy

Ringer's solution DEVICE

Ringer's solution

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Orthopedic Research and Education Foundation: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (9)

• Bedi A, Dines J, Warren RF, Dines DM. Massive tears of the rotator cuff. J Bone Joint Surg Am. 2010 Aug 4;92(9):1894-908. doi: 10.2106/JBJS.I.01531.

  PMID: 20686065 BACKGROUND

• Mendias CL, Roche SM, Harning JA, Davis ME, Lynch EB, Sibilsky Enselman ER, Jacobson JA, Claflin DR, Calve S, Bedi A. Reduced muscle fiber force production and disrupted myofibril architecture in patients with chronic rotator cuff tears. J Shoulder Elbow Surg. 2015 Jan;24(1):111-9. doi: 10.1016/j.jse.2014.06.037. Epub 2014 Sep 3.

  PMID: 25193488 BACKGROUND

• Davis ME, Stafford PL, Jergenson MJ, Bedi A, Mendias CL. Muscle fibers are injured at the time of acute and chronic rotator cuff repair. Clin Orthop Relat Res. 2015 Jan;473(1):226-32. doi: 10.1007/s11999-014-3860-y. Epub 2014 Aug 12.

  PMID: 25113269 BACKGROUND

• Gumucio JP, Flood MD, Roche SM, Sugg KB, Momoh AO, Kosnik PE, Bedi A, Mendias CL. Stromal vascular stem cell treatment decreases muscle fibrosis following chronic rotator cuff tear. Int Orthop. 2016 Apr;40(4):759-64. doi: 10.1007/s00264-015-2937-x. Epub 2015 Jul 30.

  PMID: 26224616 BACKGROUND

• Gumucio JP, Davis ME, Bradley JR, Stafford PL, Schiffman CJ, Lynch EB, Claflin DR, Bedi A, Mendias CL. Rotator cuff tear reduces muscle fiber specific force production and induces macrophage accumulation and autophagy. J Orthop Res. 2012 Dec;30(12):1963-70. doi: 10.1002/jor.22168. Epub 2012 Jun 13.

  PMID: 22696414 BACKGROUND

• Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6.

  PMID: 23570660 BACKGROUND

• Doi K, Tanaka S, Iida H, Eto H, Kato H, Aoi N, Kuno S, Hirohi T, Yoshimura K. Stromal vascular fraction isolated from lipo-aspirates using an automated processing system: bench and bed analysis. J Tissue Eng Regen Med. 2013 Nov;7(11):864-70. doi: 10.1002/term.1478. Epub 2012 Mar 22.

  PMID: 22438241 BACKGROUND

• Williams SK, Kosnik PE, Kleinert LB, Vossman EM, Lye KD, Shine MH. Adipose stromal vascular fraction cells isolated using an automated point of care system improve the patency of expanded polytetrafluoroethylene vascular grafts. Tissue Eng Part A. 2013 Jun;19(11-12):1295-302. doi: 10.1089/ten.TEA.2012.0318. Epub 2013 Mar 15.

  PMID: 23350681 BACKGROUND

• Hernigou P, Flouzat Lachaniette CH, Delambre J, Zilber S, Duffiet P, Chevallier N, Rouard H. Biologic augmentation of rotator cuff repair with mesenchymal stem cells during arthroscopy improves healing and prevents further tears: a case-controlled study. Int Orthop. 2014 Sep;38(9):1811-8. doi: 10.1007/s00264-014-2391-1. Epub 2014 Jun 7.

  PMID: 24913770 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Muscular Atrophy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Scott Rodeo, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 6, 2017
• Study Start: July 1, 2019
• Primary Completion (Estimated): June 23, 2026
• Study Completion (Estimated): July 23, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-01

Locations

US (1)