Regenerative Cell Therapy for Rotator Cuff Tears

Recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: InGeneron, Inc.

Must not be taking: Chemotherapy, Radiation

Disqualifiers: Mobility aids, Pain behavior, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Single session

246 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your pain medication usage is considered excessive by the investigator, it might affect your eligibility.

What data supports the effectiveness of the treatment Autologous Adult Adipose-Derived Regenerative Cell Injection for rotator cuff tears?

Research shows that injecting adipose-derived regenerative cells (cells taken from a person's own fat tissue) into the rotator cuff can significantly reduce shoulder pain and improve function. In one study, patients experienced a 71% reduction in shoulder pain and an 80% improvement in shoulder function, with no adverse effects reported. ^{1 2 3 4 5}

Is regenerative cell therapy for rotator cuff tears safe?

Studies show that injections of adipose-derived regenerative cells for rotator cuff tears are generally safe, with no reported adverse events in humans. These treatments have been tested in various doses and have shown improvements in shoulder function and pain relief without safety concerns. ^{2 3 4 5 6}

How is the treatment of rotator cuff tears with autologous adult adipose-derived regenerative cell injection different from other treatments?

This treatment uses a patient's own fat-derived regenerative cells, which are fresh and unmodified, to potentially improve healing in rotator cuff tears, unlike traditional methods like corticosteroid injections or surgery. It aims to enhance the body's natural repair process at the tendon-bone interface, which typically has poor healing capacity. ^{3 4 7 8 9}

Research Team

Christopher Alt, MD

Principal Investigator

InGeneron, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Subjects must have completed RC-002

Subjects can give appropriate consent

Exclusion Criteria

I am considered vulnerable and may not fully understand or agree to the study on my own.

Uncooperative subjects or those with neurological/psychiatric disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations

I need help from devices like a wheelchair or cane to walk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of either adipose-derived regenerative cells (ADRCs) or corticosteroids

Single session

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are followed for additional safety and effectiveness monitoring

3 years

Treatment Details

Interventions

• Autologous Adult Adipose-Derived Regenerative Cell Injection
• Corticosteroid Injection

Trial Overview 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.

Participant Groups

Group I: Adipose Derived Regenerative Cells Experimental Treatment 1 Intervention

a single injection of adipose-derived regenerative cells (ADRCs) into the partial-thickness rotator cuff tear

Group II: Corticosteroid Active Control 1 Intervention

a single corticosteroid injection into the subacromial space of the index arm

Who Is Running the Clinical Trial?

InGeneron, Inc.

Lead Sponsor

Trials

9

Recruited

710+

References

1. United States pubmed.ncbi.nlm.nih.gov

Perivascular Stem Cells Diminish Muscle Atrophy Following Massive Rotator Cuff Tears in a Small Animal Model. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Intratendinous Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A First-In-Human Trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intratendinous Injection of Mesenchymal Stem Cells for the Treatment of Rotator Cuff Disease: A 2-Year Follow-Up Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Enhanced Repaired Enthesis Using Tenogenically Differentiated Adipose-Derived Stem Cells in a Murine Rotator Cuff Injury Model. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Injection of adipose stem cells in the treatment of rotator cuff disease - a narrative review of current evidence. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The role of adipose derived stem cells in the treatment of rotator cuff tears: from basic science to clinical application. [2020]

8. Spain pubmed.ncbi.nlm.nih.gov

[Translated article] Efficacy of transplantation of lipoaspired mesenchymal stem cells in the treatment of chronic rotator cuff tears. Experimental model in rats. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Does an Injection of Adipose-Derived Mesenchymal Stem Cells Loaded in Fibrin Glue Influence Rotator Cuff Repair Outcomes? A Clinical and Magnetic Resonance Imaging Study. [2018]