What side effects are associated with this type of intervention?

Common treatments for rotator cuff tears, such as Adipose-Derived Regenerative Cell (ADRC) injections and platelet-rich plasma (PRP) injections, generally have minor and transient side effects. These can include pain, tenderness, swelling, and bruising at the injection site. There is also a small risk of local infection associated with any injection-based therapy. Overall, these treatments are considered safe, with most adverse effects being mild and temporary.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for Adipose-Derived Regenerative Cell (ADRC) Injections for the treatment of rotator cuff tears. However, regenerative therapies like Platelet-Rich Plasma (PRP) have been explored for similar conditions. PRP, derived from autologous blood, is known for its high concentration of growth factors that aid in tissue repair and regeneration. While PRP has shown promise in clinical trials for various musculoskeletal injuries, including tendinopathies, its use in rotator cuff tears is still under investigation, and it has not received broad FDA approval specifically for this indication.

What other types of research exist?

Promising novel alternatives to Adipose-Derived Regenerative Cell (ADRC) Injection for rotator cuff tears include Platelet-Rich Plasma (PRP) injections, which have shown efficacy in promoting tissue repair and regeneration. Autologous blood injections are another option, providing regenerative benefits through the patient's own blood components. Growth factor-based therapies, which enhance healing by delivering specific growth factors to the injury site, are also emerging as effective treatments. These alternatives have demonstrated positive outcomes in clinical trials and are likely to be viable options for patients in 2024.

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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:

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

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

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

0 / 2Eligibility criteria met

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.