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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 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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 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 more

Trial 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

Find a Location

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.

Media Library

Autologous Adult Adipose-Derived Regenerative Cell Injection (Regenerative Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT05400798 — N/A
Rotator Cuff Tears Research Study Groups: Adipose Derived Regenerative Cells, Corticosteroid
Rotator Cuff Tears Clinical Trial 2023: Autologous Adult Adipose-Derived Regenerative Cell Injection Highlights & Side Effects. Trial Name: NCT05400798 — N/A
Autologous Adult Adipose-Derived Regenerative Cell Injection (Regenerative Medicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400798 — N/A

Frequently Asked Questions

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

What is the geographic prevalence of this clinical trial?

"To name a few, this clinical trial is being carried out at Sanford Medical Center in Fargo, ND, Shrock Clinical Research in Fort Lauderdale, FL and Andrews Institute for Orthopedics and Sports Medicine in Gulf Breeze AZ. There are an additional 13 locations that are participating as well."

Answered by AI

Are there any possibilities for individuals to partake in this clinical trial at present?

"Data gathered from clinicaltrials.gov suggests that this medical trial is not accepting any more participants at present. It was first posted on January 1st 2022 and the most recent edit occurred November 17th 2022. Despite this, there are presently 105 studies actively recruiting patients."

Answered by AI

What criteria must be met to become an eligible participant in this clinical trial?

"This clinical trial is seeking 246 patients with rotator cuff tears in the age range of 30 to 75. To be considered for enrollment, applicants must adhere to two criteria: 1) completion of RC-002 and 2) being able to provide valid consent."

Answered by AI

Is this trial inclusive of participants under the age of sixty?

"This trial necessitates that participants are between 30 and 75 years old. Notably, there is a separate clinical study for individuals below 18 while 94 trials are available to those over 65 years old."

Answered by AI

Who else is applying?

What site did they apply to?
Lotus Clinical Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears
2022. "A Longitudinal, Multi-Center Safety Study of Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05400798.
~71 spots leftby Mar 2025
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