Adipose Derived Regenerative Cells for Rotator Cuff Tears

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Biosolutions Clinical Research Center, La Mesa, CA
Rotator Cuff Tears+1 More
Adipose Derived Regenerative Cells - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a longitudinal follow-up study of the RC-002 study, in which up to 246 subjects assigned to two randomization arms will be enrolled: an adipose-derived regenerative cell (ADRC) injection arm (ADRC treatment arm) and the SOC corticosteroid injection arm (active control arm). All subjects will be randomly assigned to ADRC treatment or active control arms in a 2:1 ratio and will be followed up for 6 months. The goal of the RC-004 study is to enroll all patients that were enrolled and treated in RC-002 and follow for 3 years.

Eligible Conditions

  • Rotator Cuff Tears
  • Partial Tear of Rotator Cuff

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 months

12 months
Mean improvement in VAS - Pain score compared to baseline
Mean improvement in WORC score compared to baseline
Percentage of subjects who demonstrate improvement or no worsening of supraspinatus strength on the MRC Muscle Scale compared to baseline
Percentage of subjects who demonstrate ≥ 14 mm improvement in VAS - Pain score compared to baseline
Primary Endpoint- Safety

Trial Safety

Trial Design

2 Treatment Groups

Corticosteroid
1 of 2
Adipose Derived Regenerative Cells
1 of 2
Active Control
Experimental Treatment

246 Total Participants · 2 Treatment Groups

Primary Treatment: Adipose Derived Regenerative Cells · No Placebo Group · N/A

Adipose Derived Regenerative Cells
Device
Experimental Group · 1 Intervention: Adipose Derived Regenerative Cells · Intervention Types: Device
Corticosteroid
Device
ActiveComparator Group · 1 Intervention: Corticosteroid · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Biosolutions Clinical Research Center · La Mesa, CA
2020First Recorded Clinical Trial
1 TrialsResearching Rotator Cuff Tears
7 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You can give informed consent.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.