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Regenerative Medicine
Regenerative Cell Therapy for Rotator Cuff Tears
N/A
Waitlist Available
Research Sponsored by InGeneron, Inc.
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 12 months
Awards & highlights
Study Summary
This trial is a follow-up study to the RC-002 study, in which 246 subjects will either receive an injection of regenerative cells or a corticosteroid injection as active control. The study will follow up with subjects for 6 months.
Who is the study for?
This trial is for individuals who completed the RC-002 study, can give consent, and are not undergoing chemotherapy or radiation. It excludes those using their arm for mobility aids, with disproportionate pain behavior or medication usage, vulnerable populations unable to consent, uncooperative subjects, or those with certain neurological/psychiatric disorders.Check my eligibility
What is being tested?
The study compares two treatments in people with chronic partial-thickness rotator cuff tears: an injection of adipose-derived regenerative cells (ADRC) versus a standard corticosteroid injection. Participants are randomly assigned to either treatment in a 2:1 ratio and followed up for six months.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site such as pain, swelling or infection. Since ADRC involves cell therapy from one's own fat tissue and corticosteroids are commonly used drugs, other specific side effects will be monitored throughout the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Endpoint- Safety
Secondary outcome measures
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
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Adipose Derived Regenerative CellsExperimental Treatment1 Intervention
a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear
Group II: CorticosteroidActive Control1 Intervention
a single corticosteroid injection into the subacromial space of the index arm
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Who is running the clinical trial?
InGeneron, Inc.Lead Sponsor
8 Previous Clinical Trials
465 Total Patients Enrolled
2 Trials studying Rotator Cuff Tears
183 Patients Enrolled for Rotator Cuff Tears
Christopher Alt, MDStudy DirectorInGeneron, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered vulnerable and may not fully understand or agree to the study on my own.I need help from devices like a wheelchair or cane to walk.I am currently undergoing chemotherapy or radiation treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Adipose Derived Regenerative Cells
- Group 2: Corticosteroid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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