Regenerative Cell Therapy for Rotator Cuff Tears

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new treatments for rotator cuff tears, a common shoulder injury. It compares two treatments: an injection of adipose-derived regenerative cells from a person's own body fat and a standard corticosteroid injection. The study aims to evaluate the effectiveness of these treatments over three years. Individuals from the previous study with a rotator cuff tear may qualify for this trial, provided they do not require their arms for walking aids like crutches or a wheelchair. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using special cells from fat tissue, known as adipose-derived regenerative cells (ADRCs), to treat certain shoulder injuries is generally safe. Studies have found that ADRC injections often improve shoulder movement and carry low risks. One study suggested that the risks of using ADRCs are similar to those of standard treatments, such as steroid injections. These studies reported no major side effects, making ADRCs a promising option for those considering participation in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the autologous adult adipose-derived regenerative cell (ADRC) injection for rotator cuff tears because it uses the body's own cells to promote healing. Unlike traditional treatments like physical therapy or corticosteroid injections, which mainly focus on reducing inflammation and pain, ADRC injections aim to regenerate damaged tissue. By utilizing regenerative cells harvested from a patient's own fat tissue, this approach offers a potentially more natural and effective way to repair partial-thickness tears in the rotator cuff. The unique mechanism of directly enhancing tissue regeneration sets it apart from existing therapies.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

Research has shown that injections using a person's own fat cells, such as the Autologous Adult Adipose-Derived Regenerative Cell Injection studied in this trial, can help treat partial tears in the shoulder's rotator cuff. Studies have found these injections to be safe and capable of improving shoulder function. Specifically, patients who received these injections experienced significant improvement in shoulder movement without negative side effects. This trial will compare the effectiveness of these regenerative cell injections with Corticosteroid Injections, a traditional treatment. These findings support the potential of regenerative cell therapy to enhance the quality of life for people with rotator cuff injuries. ^{1 2 3 4 6}

Who Is on the Research Team?

Christopher Alt, MD

Principal Investigator

InGeneron, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03752827

Autologous Adult Adipose-Derived Regenerative Cell ...

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator ...

2.

nature.com

nature.com/articles/s41598-023-46653-4

Management of partial-thickness rotator cuff tears with ...

Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7110715/

Safety and efficacy of treating symptomatic, partial ...

This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects.

4.

link.springer.com

link.springer.com/chapter/10.1007/978-3-030-73299-8_5

Autologous Adult Adipose-Derived Regenerative Cell ...

The purpose of this investigation is to evaluate the safety and superior effectiveness in functional improvement in patients with partial-thickness rotator ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7459379/

The role of adipose derived stem cells in the treatment ...

The purpose of this study was to provide a state of the art about the current basic science and clinical literature for the effectiveness of adipose derived ...

6.

medrxiv.org

medrxiv.org/content/10.1101/2022.12.14.22283447v2.full-text

Long-term safety and efficacy of treating symptomatic ...

This study also showed that the risks associated with treating sPTRCT with UA-ADRCs were as low as those associated with injection of ...