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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to heal rotator cuff tears, which affect the shoulder's muscles and tendons. Researchers aim to determine if adding decellularized human placental extracellular matrix tissue, derived from human placentas and stripped of cells, can enhance healing when combined with standard rotator cuff repair surgery. Participants will be randomly assigned to receive either the additional tissue or not, and all will undergo an MRI a year after surgery to assess healing. The trial seeks adults diagnosed with a full-thickness tear in their rotator cuff who have not undergone previous rotator cuff surgery. As a Phase 2, Phase 3 trial, it evaluates the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering participants an opportunity to contribute to medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that using a special tissue from the human placenta, called decellularized extracellular matrix, holds promise for repairing rotator cuff injuries in both animals and humans. In past studies, this treatment reduced the chances of re-injury and improved recovery after surgery.

The treatment involves tissue with its cells removed, leaving a framework that supports the body's own cells to grow and repair the rotator cuff more effectively. Although still under investigation, current studies suggest it is generally safe and well-tolerated, with no major harmful side effects reported so far.

Since the trial is in advanced stages, earlier safety tests have already been completed. This typically indicates that the treatment has shown a good safety record in previous research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for rotator cuff tears involve standard surgical repair techniques. However, this new treatment is unique because it uses decellularized human placental extracellular matrix tissue as an allograft. This material can support tissue regeneration and healing more effectively by providing a natural scaffold that encourages cell growth and integration with the patient’s tissue. Researchers are excited about this approach as it has the potential to improve healing outcomes and reduce recovery time, offering a promising alternative to current methods.

What evidence suggests that this treatment might be an effective treatment for rotator cuff tears?

Research has shown that using a special tissue from the human placenta can help treat rotator cuff tears. This tissue is prepared to remove all cells, ensuring safety. In this trial, participants in the treatment arm will receive standard rotator cuff repair along with this allograft treatment. Studies have found that this approach reduces the risk of the rotator cuff tearing again after surgery and improves patients' feelings and function afterward. Animal studies also support its potential to enhance healing. Overall, this treatment appears promising for improving the success of rotator cuff repairs. ^{1 2 3 6 7}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07027735

Study Details | NCT07027735 | Decellularized Human ... Decellularized ECM treatment was shown to both reduce retear rate and improve patient outcome scores when used in the treatment of large to massive rotator cuff ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07027735?term=AREA%5BLastUpdatePostDate%5D%20RANGE%5B2020-03-25,MAX%5D&rank=4

Decellularized Human Placental Extracellular Matrix Tissue for ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867272/

Decellularized biological matrices for the repair of rotator ... This review provides a comprehensive overview of the use of acellular patches and their effective therapeutic potential in rotator cuff (RC) repair

4. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05596-4

a comparison study of patch sterilization and storage methods Decellularized tendon patch enhance biological and mechanical healing of large-to-massive rotator cuff tear in a rat chronic model: a comparison ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2452199X2400077X

Engineering an extracellular matrix-functionalized, load ... The BioTenoForce scaffold, a load-bearing tendon substitute with pro-regenerative properties, exhibits remarkable efficacy in repairing large-to-massive rotator ...

6. withpower.com withpower.com/trial/phase-2-and-3-rotator-cuff-tears-7-2025-3fa75

Placental Tissue for Rotator Cuff Tears (ECMRCR Trial) Trial Overview The study tests if adding a decellularized human placental extracellular matrix allograft patch improves healing in rotator cuff repair surgeries ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452199X23003006

Decellularized extracellular matrix biomaterials for ... This article underscores the potential of dECM biomaterials to stimulate in situ tissue repair through chemotactic effects for the development of growth factor.