Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears

NCT05264922 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 1719310
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tears

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  24 months

Secondary Outcomes (3)

• Patient-reported measures Western Ontario Rotator Cuff (WORC) Index

  24 months

• Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)

  24 months

• Patient-reported measures Visual Analog Scale (VAS)

  24 months

Study Arms (2)

Fibrin Glue

ACTIVE COMPARATOR

Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution

Drug: Tisseel Injectable Product

SVF cells and Fibrin Glue

EXPERIMENTAL

Nucleated adipose-derived cells loaded in a fibrin glue scaffold

Drug: Tisseel Injectable Product; Biological: Stromal Vascular Fraction Cells

Interventions

Tisseel Injectable Product DRUG

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.

Also known as: Fibrin Glue

Fibrin Glue; SVF cells and Fibrin Glue

Stromal Vascular Fraction Cells BIOLOGICAL

Stromal Vascular Fraction cells are autologously harvested, processed and reinjected into the affected shoulder.

SVF cells and Fibrin Glue

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Tariq Awan, DO

  AdventHealth Orlando

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The provider (PI) and team performing the injection will not care for the subject during follow up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to SVF Cells \& Fibrin Glue or Fibrin Glue alone.

Study Record Dates

• First Submitted: December 27, 2021
• First Posted: March 3, 2022
• Study Start: January 9, 2022
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)