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Regenerative Medicine

ADRC Injection for Rotator Cuff Tears

N/A
Waitlist Available
Led By Jason Hurd, MD
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 and 24 weeks
Awards & highlights

Study Summary

This trial is testing whether a single injection of ADRCs into partial-thickness rotator cuff tears is more effective and results in more functional improvement than a single corticosteroid injection in the same area.

Who is the study for?
Adults aged 30-75 with chronic partial-thickness tears in the rotator cuff who experience pain and limited motion, but haven't had recent shoulder surgery or steroid injections. Excluded are those with severe joint issues, full-thickness tears, certain medical conditions like cancer within the last 5 years, immune diseases requiring systemic treatment, or allergies to specific anesthetics.Check my eligibility
What is being tested?
The trial is testing if a single injection of adipose-derived regenerative cells (ADRCs) into the tear can improve shoulder function more effectively than a standard corticosteroid injection into the subacromial space for patients with partial-thickness rotator cuff tears.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection site, allergic reactions to components in ADRC preparation or anesthesia used during procedure. Corticosteroids might cause local tissue damage or weakening of tendons over time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Pain: VAS
Improvement or no worsening in supraspinatus strength
Secondary outcome measures
Mean improvement in VAS - Pain score
Mean improvement in WORC score
Percentage of subjects who demonstrate a ≥ 1-grade improvement in supraspinatus strength on the MRC Muscle Scale
+2 more
Other outcome measures
Mean improvement in Rand Short Form-36 score
Measurement of EuroQoL-5D-5L (EQ-5D-5L)
Measurement of Shoulder Activity Level
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Adipose Derived Regenerative CellsExperimental Treatment1 Intervention
Adipose-derived regenerative cell injection into the area of the supraspinatus tendon tear
Group II: CorticosteroidActive Control1 Intervention
Subjects in the active control arm will receive a corticosteroid injection into the subacromial space using ultrasound (US) guidance.

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Who is running the clinical trial?

InGeneron, Inc.Lead Sponsor
8 Previous Clinical Trials
543 Total Patients Enrolled
Jason Hurd, MDPrincipal InvestigatorSanford Orthopedics & Sports Medicine

Media Library

Rotator Cuff Tendinitis Research Study Groups: Corticosteroid, Adipose Derived Regenerative Cells
~28 spots leftby Jun 2025
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