Placental Tissue for Rotator Cuff Tears

(ECMRCR Trial)

Overseen By Andrew J Luzzi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Columbia University

Disqualifiers: Partial tears, Subscapularis tears, Goutallier 3/4, Prior surgery

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: Surgery day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The rotator cuff is a set of muscles and tendons that help move the shoulder. Tears in the rotator cuff are common, particularly as people age. Consequently, rotator cuff repair surgeries are common, as well. Despite the frequency with which rotator cuff repairs are performed, there remains a high rate of postoperative failure to heal. In such situations, there is a lack of connective tissue establishment between the rotator cuff tendon and the bone. One strategy to attempt to improve healing of the rotator cuff tendon back to the bone is via the use of extracellular matrix allograft. This treatment is composed of tissue from other humans, which is stripped of its cells so that just the scaffolding around the cells remains. This decellularized scaffolding can be placed at the rotator cuff healing site in an attempt to augment healing. Both animal studies and human studies have shown promise with this approach. Of those patients enrolling in the study, 50% will be assigned at random to receive a standard rotator cuff repair AND allograft treatment, while 50% will be assigned at random to receive standard rotator cuff repair WITHOUT allograft treatment. All patients enrolled in the study will also obtain an MRI at one year following surgery in order to assess tendon healing. Of note, one-year postoperative MRIs are not standard following rotator cuff repair - only those enrolled in the study will receive this MRI. There will be no financial consequence of receiving this MRI.

Who Is on the Research Team?

William Levine, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for individuals with rotator cuff tears or injuries who are undergoing repair surgery. Participants must be suitable for surgical intervention and willing to undergo MRI scans one year post-surgery, which isn't standard care. Details on specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

I have a complete tear in my shoulder's rotator cuff.

I am 18 years old or older.

Exclusion Criteria

Partial thickness tears

My muscle degeneration is severe.

I have had surgery on my rotator cuff before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Clearance

Patients receive preoperative clearance and screening for infectious diseases

1-2 weeks

Treatment

Patients undergo standard arthroscopic rotator cuff repair with or without decellularized ECM

Surgery day

1 visit (in-person)

Postoperative Follow-up

Patients are monitored postoperatively at 2 weeks, 3 months, 6 months, and 12 months

12 months

4 visits (in-person)

MRI Assessment

MRI performed at 12 months to assess tendon healing and retear rate

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Decellularized Human Placental Extracellular Matrix Tissue

Trial Overview The study tests if adding a decellularized human placental extracellular matrix allograft patch improves healing in rotator cuff repair surgeries. Half the patients will receive this augmentation randomly, while the other half will have standard repairs without it.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Standard Rotator Cuff Repair + Receives Allograft Treatment

Group II: Control Arm Experimental Treatment 1 Intervention

Standard Rotator Cuff Repair + NO Allograft Treatment

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

CTM Biomedical

Industry Sponsor

Trials

5

Recruited

200+