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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

SVF Trial Summary

This trial is testing whether injecting cells from fat tissue can help repair small rotator cuff tears without surgery.

Eligible Conditions

Rotator Cuff Tears

SVF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Efficacy - MRI-measured healing rate in the rotator cuff tear

Primary Safety - Incidence/Rates of adverse events (AEs) involving the affected joint

Secondary outcome measures

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

SVF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AdventHealthLead Sponsor

106 Previous Clinical Trials

29,537 Total Patients Enrolled

Tariq Awan, DOPrincipal InvestigatorAdventHealth Orlando

Frequently Asked Questions

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

Does the FDA recognize Stromal Vascular Fraction Cells as a safe treatment?

"While there is some evidence that Stromal Vascular Fraction Cells are safe, as this is only a Phase 2 trial, the lack of data surrounding efficacy gives it a score of 2."

Answered by AI

For whom does this research project qualify?

"This study needs 48 individuals, both male and female, that are between 30-65 years old. The patients must also have a rotator cuff tear as well as being a good candidate for lipoaspiration and autologous adipose derived stem cell therapy."

Answered by AI

Are patients still being recruited for this clinical trial?

"Per the information available on clinicaltrials.gov, this research is actively recruiting participants. The trial was first announced on October 1st, 2020 and was last updated February 22nd, 2021. They are seeking 48 individuals from a single location."

Answered by AI

Does this research project require participants to be over 25 years old?

"This particular study is only for patients aged 30-65. If you are outside of this age bracket, there may be other trials more suited for you; 10 focus on those under 18 while 99 cater to seniors."

Answered by AI

How many people are being signed up for this clinical trial?

"That is correct. The listed information on clinicaltrials.gov states that the trial is still actively recruiting patients. This particular study was first posted on 1/10/2022 and edited on 2/22/2022. They are looking for a total of 48 participants at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Stromal Vascular Fraction (SVF) Cells for Non-Operative Treatment of Small Rotator Cuff Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05264922.