← Back to Search

SVF Cell Therapy for Rotator Cuff Tears

Phase 2
Waitlist Available
Led By Scott Rodeo, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm
Males and females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
Awards & highlights

Study Summary

This trial will determine if the use of stromal vascular fraction cells (SVFCs) from subcutaneous adipose tissue can improve outcomes for patients undergoing surgical repair of a torn supraspinatus rotator cuff.

Who is the study for?
This trial is for men and women aged 45-65 with a full-thickness tear in the supraspinatus tendon of the rotator cuff, who have enough belly fat for a small liposuction, and whose blood work meets certain standards. They should have tried physical therapy without success. People with diabetes, high cholesterol, significant past illnesses or surgeries, other tendon tears besides supraspinatus, severe joint arthritis, previous rotator cuff repairs or serious arm injuries can't join.Check my eligibility
What is being tested?
The trial tests if injecting patients' own SVF cells (from their belly fat) into their torn rotator cuff during surgery helps repair better than just using Ringer's solution. The idea is that these cells could turn into muscle or tendon cells or release helpful substances to improve healing after surgery.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks like infection and pain at the injection site. There might also be issues related to liposuction such as bruising or numbness around the area where fat was taken.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a severe shoulder tendon tear not retracted more than 3 cm.
Select...
I am either male or female.
Select...
I am between 45 and 65 years old.
Select...
I still have pain and can't move well after 6 weeks of physical therapy.
Select...
I have enough belly fat for a minor fat removal procedure.
Select...
My MRI shows minimal to moderate fatty muscle changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks prior to surgery, 6 weeks after surgery, 6 months after surgery, 12 months after surgery, 24 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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 fatty infiltration from baseline, measured by magnetic resonance imaging
Change in supraspinatus muscle stiffness from baseline, measured by ultrasound shear wave elastrography

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Cell TherapyActive Control1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
Patients will receive an injection of vehicle (Ringer's solution) into their supraspinatus muscle and tendon at the time of rotator cuff repair

Find a Location

Who is running the clinical trial?

Orthopedic Research and Education FoundationOTHER
19 Previous Clinical Trials
11,344 Total Patients Enrolled
Hospital for Special Surgery, New YorkLead Sponsor
242 Previous Clinical Trials
61,846 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
472 Patients Enrolled for Rotator Cuff Tears
Scott Rodeo, MDPrincipal InvestigatorHospital for Special Surgery, New York
2 Previous Clinical Trials
38 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
20 Patients Enrolled for Rotator Cuff Tears

Media Library

Cell Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03332238 — Phase 2
Rotator Cuff Tears Research Study Groups: Placebo, Cell Therapy
Rotator Cuff Tears Clinical Trial 2023: Cell Therapy Highlights & Side Effects. Trial Name: NCT03332238 — Phase 2
Cell Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03332238 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can I join this research project?

"The ideal candidate for this clinical trial would be between 45-65 years of age with some form of muscle tissue. Right now, the study is looking to recruit 56 patients in total."

Answered by AI

Are patients currently being accepted into this trial program?

"The clinical trial is still recruiting patients, as of the 27th of July in 2022, and was originally posted on the 1st of July in 2019."

Answered by AI

Are geriatric patients being considered for this research?

"In order to be eligible for this clinical trial, applicants must between the ages of 45 and 65. This specific trial has 59 child participants and 249 senior citizens enrolled."

Answered by AI

Is Cell Therapy a dangerous medical treatment?

"Cell Therapy's safety was given a score of 2 by our team because, although there is data supporting safety, cell therapy has not yet been proven effective."

Answered by AI

How competitive is this study in terms of participant selection?

"That is correct. The study's information page on clinicaltrials.gov says that it is currently looking for 56 individuals to take part in the trial at 1 location."

Answered by AI
Recent research and studies
~11 spots leftby Jun 2025