Rotator Cuff TearsPhase 2SVFNCT05264922
Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears
A Phase 2 study testing Tisseel Injectable Product and Stromal Vascular Fraction Cells in people with Rotator Cuff Tears, run by AdventHealth at 1 site in United States.
Trial summary
The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Tisseel Injectable Product and Stromal Vascular Fraction Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2022to 22 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients 30-65 years of age
- Symptomatic partial-thickness rotator cuff tears
- Suitable candidate for lipoaspiration and autologous adipose derived stem cell therapy as per physician.
Who cannot join
- History of RC repair of affected shoulder, osteomyelitis or septic arthritis;
- Primary diagnosis of osteoarthritis, primary adhesive capsulitis;
- Full thickness rotator cuff tear
- RC tear of the subscapularis (SSc) or teres minor (TM), or a RC tear at the musculotendinous junction.
- Prescribed physical therapy or injection (of any nature) to shoulder prior to initial visit (within past 3 months);
- Clinically significant medical diseases that can impact tissue healing (i.e. Cardiovascular/peripheral vascular disease, diabetes, cancer, endocrine disease, hepatic disease (hepatitis), renal disease, autoimmune/inflammatory disease, HIV;
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- Cervical spine radiculopathy;
- Current anticoagulation therapy (excluding Aspirin 81mg), immunosuppressant medication, narcotic use;
- Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraception for the first year of the study (i.e. oral contraceptive, barrier method, intrauterine device (IUD), intramuscular contraceptive);
- Subjects with abnormal hematology or serum chemistry lab results, outside of the normal range, as defined by the American Board of Internal Medicine (ABIM) Laboratory Test Reference Ranges, which are clinically significant, in the opinion of the investigator;
- BMI greater than 40 kg/m2;
- History of tobacco use within last 3 years;
- Subject has been diagnosed with any bleeding disorders, including but not limited to: hemophilia A or B, Von Willebrand Disease;
- Currently participating, or has participated in any other clinical trials within 6 months prior to the screening visit;
- Subjects has any significant medical condition, that in the option of the investigator, would make them unable to provide informed consent and/or interfere with their compliance of study requirements;
- Subject has a documented allergy to the anesthetic or any component of the injectable, including but not limited to: aprotinin.
- Subject has a contraindication for completing the MRI (i.e. pacemaker, aneurysm clip, metal fragments, etc that may become dislodged) or has problems with loud noises or claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.
Read the detailed description
Small rotator cuff tendon tears are a hard task in shoulder care. They are often not operated on because research has not shown any increased benefit of surgery over physical therapy. The most common way to treat these tears is through physical therapy or steroid injections. However, the relief doesn't last very long. Recent studies have shown a lot of tears get worse over time. This happens because the physical therapy options can treat the pain and symptoms, but do not heal the actual tear.
Another non-surgical option for treating small tears is through adipose-derived stem cells. Adipose-derived stem cells are cells that are found in the fat in our bodies. The cells have shown promise in fixing tissues and may provide help to treat small rotator cuff tears. The investigators are studying a part of these fat cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. This is important because they may be able to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used these cells to help small tears without surgery. The use of SVF is investigational. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). The FDA is allowing the use of this drug for research. The investigators goal is to determine the effectiveness of SVF cell injection to treat small rotator cuff tears without surgery.
- Conditions
- Rotator Cuff Tears
- Being tested
- Tisseel Injectable Product, Stromal Vascular Fraction Cells
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisseel Injectable ProductDrug
Also called Fibrin Glue
Fibrin glue will provide an inert, biocompatible, viscous substance able to remain within the Rotator Cuff (RC) defect rather than injecting SVF cells in saline.
Stromal Vascular Fraction CellsBiological
Stromal Vascular Fraction cells are autologously harvested, processed and reinjected into the affected shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Glue | Active comparator | Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution Receives: Drug: Tisseel Injectable Product |
| SVF cells and Fibrin Glue | Experimental | Nucleated adipose-derived cells loaded in a fibrin glue scaffold Receives: Drug: Tisseel Injectable Product; Biological: Stromal Vascular Fraction Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear
Healing rates between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.
Measured: 24 months
Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint
Both study-related AE assessments and the clinical record will be interrogated to determine if the subjects had any adverse events involving the affected joint. Incidence and rates of AEs between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.
Measured: 24 months
Secondary outcomes (3)
Patient-reported measures Western Ontario Rotator Cuff (WORC) Index
WORC score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. The investigators expect the SVF-treated patients to improve by over 12% on the WORC at the final 2-yr follow-up.
Measured: 24 months
Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)
PROMIS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP.expect the SVF-treated patients to improve by 10 points on the PROMIS at the final 2-yr follow-up.
Measured: 24 months
Patient-reported measures Visual Analog Scale (VAS)
Pain VAS score - Compare clinical outcomes between treatment with stromal vascular fraction (SVF) cells and EP and sham injection and EP. expect the SVF-treated patients to improve by over 12% on the WORC, by 10 points on the PROMIS, and by 20% on the pain VAS by the final 2-yr follow-up. expect the SVF-treated patients to improve by 20% on the pain VAS at the final 2-yr follow-up.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start9 Jan 2022
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Why it stopped: Study never started. PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Subjects will be randomized 1:1 to SVF Cells \& Fibrin Glue or Fibrin Glue alone.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tariq Awan, DO, Principal investigator, AdventHealth Orlando
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264922
- Sponsor's protocol ID
- 1719310
- Acronym
- SVF
- Status last verified
- Feb 2023
- First submitted
- 27 Dec 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05264922
- Acronym / sponsor ID
- SVF / 1719310
- Conditions
- Rotator Cuff Tears
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started. PI left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator's goal is to determine the effectiveness of stromal vascular fraction (SVF) cell injection to treat small rotator cuff tears without surgery.
Detailed description
Small rotator cuff tendon tears are a hard task in shoulder care. They are often not operated on because research has not shown any increased benefit of surgery over physical therapy. The most common way to treat these tears is through physical therapy or steroid injections. However, the relief doesn't last very long. Recent studies have shown a lot of tears get worse over time. This happens because the physical therapy options can treat the pain and symptoms, but do not heal the actual tear.
Another non-surgical option for treating small tears is through adipose-derived stem cells. Adipose-derived stem cells are cells that are found in the fat in our bodies. The cells have shown promise in fixing tissues and may provide help to treat small rotator cuff tears. The investigators are studying a part of these fat cells known as the stromal vascular fraction (SVF). The SVF contains a number of cells that are able to become a variety of different cells. This is important because they may be able to turn into cells that may help heal the damaged rotator cuff tendons. These cells have been shown to improve results after rotator cuff surgery, but no research has used these cells to help small tears without surgery. The use of SVF is investigational. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA). The FDA is allowing the use of this drug for research. The investigators goal is to determine the effectiveness of SVF cell injection to treat small rotator cuff tears without surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to SVF Cells \& Fibrin Glue or Fibrin Glue alone.
| Arm | Type | Receives |
|---|---|---|
| Fibrin Glue | Active comparator | Drug: Tisseel Injectable ProductSingle 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution |
| SVF cells and Fibrin Glue | Experimental | Drug: Tisseel Injectable Product, Biological: Stromal Vascular Fraction CellsNucleated adipose-derived cells loaded in a fibrin glue scaffold |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patients 30-65 years of age
- Symptomatic partial-thickness rotator cuff tears
- Suitable candidate for lipoaspiration and autologous adipose derived stem cell therapy as per physician.
Key exclusion criteria (17 listed)
- History of RC repair of affected shoulder, osteomyelitis or septic arthritis;
- Primary diagnosis of osteoarthritis, primary adhesive capsulitis;
- Full thickness rotator cuff tear
- RC tear of the subscapularis (SSc) or teres minor (TM), or a RC tear at the musculotendinous junction.
- Prescribed physical therapy or injection (of any nature) to shoulder prior to initial visit (within past 3 months);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tisseel Injectable ProductAlso: Fibrin GlueFibrin glue will provide an inert, biocompatible, viscous substance able to remain within the Rotator Cuff (RC) defect rather than injecting SVF cells in saline. | Drug | Fibrin Glue, SVF cells and Fibrin Glue |
| Stromal Vascular Fraction CellsStromal Vascular Fraction cells are autologously harvested, processed and reinjected into the affected shoulder. | Biological | SVF cells and Fibrin Glue |
Primary outcome
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear
Time frame: 24 months
Healing rates between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.
Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint
Time frame: 24 months
Both study-related AE assessments and the clinical record will be interrogated to determine if the subjects had any adverse events involving the affected joint. Incidence and rates of AEs between the treatment with stromal vascular fraction (SVF) cells and exercise program (EP) group will be compared to the sham and EP group.
3 secondary outcomes
Patient-reported measures Western Ontario Rotator Cuff (WORC) Index
Time frame: 24 months
Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: 24 months
Patient-reported measures Visual Analog Scale (VAS)
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
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Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tariq Awan, DO principal investigator
AdventHealth Orlando
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tisseel Injectable Product and Stromal Vascular Fraction Cells in people with Rotator Cuff Tears, run by AdventHealth 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 3 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: withdrawn, as of the sponsor's last update on 15 Feb 2023. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.