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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
Must not have
Subjects who require the use of index arm for ambulation or mobilization via wheelchair, walker, crutches or cane
Subject is on an active regimen of chemotherapy or radiation-based treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial involves two treatments: one with healing cells from fat tissue and another with an anti-inflammatory drug. The healing cells aim to repair tissue, while the drug reduces inflammation.
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need help from devices like a wheelchair or cane to walk.
Select...
I am currently undergoing chemotherapy or radiation treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Endpoint- Safety
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Rotator Cuff Tears include corticosteroid injections, platelet-rich plasma (PRP) injections, and adipose-derived regenerative cell (ADRC) injections. Corticosteroid injections reduce inflammation and pain but do not promote tissue healing.
PRP injections utilize concentrated platelets from the patient's blood to release growth factors that aid in tissue repair and regeneration. ADRC injections, which are being studied in trials, involve the use of regenerative cells derived from the patient's adipose (fat) tissue.
These cells have the potential to differentiate into various cell types and release bioactive molecules that promote tissue repair, reduce inflammation, and enhance healing. For patients with Rotator Cuff Tears, treatments that promote tissue regeneration, like ADRC and PRP, are particularly valuable as they address the underlying damage and support the restoration of tendon function, potentially leading to better long-term outcomes.
Factors affecting healing after arthroscopic rotator cuff repair.
Factors affecting healing after arthroscopic rotator cuff repair.
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
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.