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

Primary Purpose

Rotator Cuff Tear, Muscle Atrophy, Tendon Tear

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Autologous Stomal Vascular Fraction Material

Ringer's solution

About this trial

This is an interventional treatment trial for Rotator Cuff Tear

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital for Special SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Cell Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT03332238

First Posted

October 30, 2017

Last Updated

May 23, 2023

Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthopedic Research and Education Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03332238

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

January 23, 2024 (Anticipated)

Study Completion Date

January 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital for Special Surgery, New York

Collaborators

Orthopedic Research and Education Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear, Muscle Atrophy, Tendon Tear

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Cell Therapy

Arm Type

Active Comparator

Arm 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

Intervention Type

Device

Intervention Name(s)

Autologous Stomal Vascular Fraction Material

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Ringer's solution

Intervention Description

Ringer's solution

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Edon, MS, CSCS

Phone

212-774-7833

EdonD@hss.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Rodeo, MD

Organizational Affiliation

Hospital for Special Surgery, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital for Special Surgery

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Edon, MS, CSCS

Phone

212-774-7833

EdonD@hss.edu

First Name & Middle Initial & Last Name & Degree

Bridget Hayes, MS

Phone

212-774-7154

Hayesb@hss.edu

First Name & Middle Initial & Last Name & Degree

Scott Rodeo, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20686065

Citation

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.

Results Reference

background

PubMed Identifier

25193488

Citation

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.

Results Reference

background

PubMed Identifier

25113269

Citation

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.

Results Reference

background

PubMed Identifier

26224616

Citation

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.

Results Reference

background

PubMed Identifier

22696414

Citation

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.

Results Reference

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PubMed Identifier

23570660

Citation

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.

Results Reference

background

PubMed Identifier

22438241

Citation

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.

Results Reference

background

PubMed Identifier

23350681

Citation

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.

Results Reference

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PubMed Identifier

24913770

Citation

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.

Results Reference

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

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