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Cell Therapy

Stromal Vascular Fraction Cells for Rotator Cuff Tears (SVF Trial)

Phase 2
Waitlist Available
Led By Tariq Awan, DO
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether injecting special cells from body fat can help heal small tears in the shoulder's rotator cuff without surgery. These patients often don't get lasting relief from physical therapy or steroid injections. The injected cells might turn into new tendon cells, potentially fixing the tear and improving shoulder function. Previous studies have shown promise in using these cells to improve tendon health.

Eligible Conditions
  • Rotator Cuff Tears

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy - MRI-measured healing rate in the rotator cuff tear
Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint
Secondary study objectives
Patient-reported measures Patient Reported Outcomes Measurement Information System (PROMIS)
Patient-reported measures Visual Analog Scale (VAS)
Patient-reported measures Western Ontario Rotator Cuff (WORC) Index

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SVF cells and Fibrin GlueExperimental Treatment2 Interventions
Nucleated adipose-derived cells loaded in a fibrin glue scaffold
Group II: Fibrin GlueActive Control1 Intervention
Single 4 milliliter (mL) injection of 0.9% normal saline and fibrin glue solution

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Who is running the clinical trial?

AdventHealthLead Sponsor
115 Previous Clinical Trials
31,365 Total Patients Enrolled
Tariq Awan, DOPrincipal InvestigatorAdventHealth Orlando
~0 spots leftby Nov 2025
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