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Rotator Cuff TearPhase 2NCT03332238

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

A Phase 2 study testing Autologous Stomal Vascular Fraction Material and Ringer's solution in people with Rotator Cuff Tear and Muscle Atrophy, run by Hospital for Special Surgery, New York at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Rotator Cuff Tear, Muscle Atrophy, Tendon Tear
What is being tested?
Autologous Stomal Vascular Fraction Material and Ringer's solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteUnited States
Study dates
1 Jul 2019to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

Official title: 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.

Being tested
Autologous Stomal Vascular Fraction Material, Ringer's solution
Medical subject headings
Rotator Cuff Injuries, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Stomal Vascular Fraction MaterialDevice

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

  • Ringer's solutionDevice

    Ringer's solution

Study groups in NCT03332238
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPatients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair
Receives: Device: Ringer's solution
Cell TherapyActive comparatorPatients 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
Receives: Device: Autologous Stomal Vascular Fraction Material

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (3)

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study start1 Jul 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03332238
Sponsor's protocol ID
2017-0999
Status last verified
Aug 2026
First submitted
30 Oct 2017
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 20686065

  • 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.

    PubMed 25193488

  • 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.

    PubMed 25113269

  • 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.

    PubMed 26224616

  • 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.

    PubMed 22696414

  • 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.

    PubMed 23570660

  • 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.

    PubMed 22438241

  • 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.

    PubMed 23350681

  • 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.

    PubMed 24913770

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Autologous Stomal Vascular Fraction Material and Ringer's solution in people with Rotator Cuff Tear and Muscle Atrophy, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03332238, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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