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

NCT05264922 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-02-15

No results posted yet for this study

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

Interventions

DRUG

Tisseel Injectable Product

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.

BIOLOGICAL

Stromal Vascular Fraction Cells

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

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Tariq Awan, DO · AdventHealth Orlando

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-09
Primary Completion
2022-07-22
Completion
2022-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05264922 on ClinicalTrials.gov