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Cell Therapy

Cellular Stromal Vascular Fraction for Tendinopathy (BRT Trial)

N/A

Waitlist Available

Led By Ryan JP Welter, MD, PhD

Research Sponsored by Robert W Alexander, MD

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 baseline, 1 year

Awards & highlights

BRT Trial Summary

This trial is testing a new therapy for treating musculoskeletal disorders, which are injuries or pain in the body's joints, muscles, nerves, and bones. The therapy uses cells from the patient's own fat or bone marrow, which are injected into the affected area. The study is designed to see if this is a safe and effective treatment.

Eligible Conditions

Tendinopathy
Back Pain
Osteoarthritis
Tendinosis
Rheumatoid Nodule

BRT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Participants with complications

Secondary outcome measures

Change from baseline of imaging if required for study entry

Change from baseline of limitation of activities (Functional analysis of range of motion)

Change from baseline quality of life level (QoL Questionnaire)

+1 more

BRT Trial Design

3Treatment groups

Experimental Treatment

Group I: tSVF + PRP Arm1Experimental Treatment2 Interventions

Stromal Vascular Fraction tSVF + Platelet Rich Plasma (PRP) concentrate

Group II: tSVF + PRP + cSVF Enrichment Arm 2Experimental Treatment3 Interventions

tissue Stromal Vascular Fraction (tSVF) + Platelet-Rich Plasma (PRP) concentration + (cSVF)

Group III: Normal Saline IV + cSVF Arm 3Experimental Treatment2 Interventions

Cellular Stromal Vascular Fraction (cSVF); Normal Saline IV introduction

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma

2016

Completed Phase 4

~1100

Normal Saline

2019

Completed Phase 4

~1770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Regeneris MedicalOTHER

3 Previous Clinical Trials

380 Total Patients Enrolled

Robert W Alexander, MDLead Sponsor

Global Alliance for Regenerative MedicineOTHER

4 Previous Clinical Trials

460 Total Patients Enrolled

Frequently Asked Questions

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

Are there still opportunities for people to join this trial?

"Clinicaltrials.gov confirms that this research trial is currently seeking participants. The study was launched on March 11th 2017 and the latest update was posted on January 13th 2020."

Answered by AI

Is it possible to become a participant in this investigation?

"To be eligible for this medical trial, prospective participants must have degenerative joint disease and fall between the ages of 18 to 90. The program is currently accepting up to 300 people."

Answered by AI

Is there an upper limit to the number of participants included in this clinical experiment?

"Affirmative. According to information on clinicaltrials.gov, the trial that was originally posted on March 11th 2017 is currently recruiting participants. The research team needs 300 volunteers at a single site to complete their study."

Answered by AI