Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation

Launched by COLUMBIA UNIVERSITY · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help people heal better after surgery for a torn rotator cuff—a group of muscles and tendons that help move the shoulder. Sometimes, after rotator cuff surgery, the tendon doesn’t heal well back to the bone. This study is testing whether adding a special tissue made from donated human placenta (with its cells removed, leaving a natural “scaffold”) can help improve healing when placed at the surgery site.

Adults who have a full-thickness rotator cuff tear (meaning the tear goes all the way through the tendon) may be eligible to join, as long as they haven’t had previous rotator cuff surgery and don’t have certain other shoulder conditions. Half of the participants will have the usual rotator cuff repair surgery plus this new tissue added, and the other half will have the standard surgery without it. One year after surgery, everyone in the study will get an MRI scan to see how well the tendon has healed—this MRI is not normally done after this surgery and will be provided at no cost. The study is not yet recruiting but is open to adults of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Diagnosis of full thickness rotator cuff tear
• Exclusion Criteria:
• • Partial thickness tears
• • Full thickness subscapularis tears
• • Goutallier grades 3 and 4
• • Prior rotator cuff surgery