Mesenchymal Stem Cells and Amniotic Membrane Composite for Supraspinatus Tendon Repair Augmentation

Dr. Soetomo General Hospital

Status: Unknown

Conditions: Supraspinatus Tear

Treatments: Procedure: Tendon repair procedure; Procedure: Tendon repair augmented with AAdMSC-HAM composite

Study type: Interventional

Funder types: Other

Identifiers

NCT04670302

1208/KEPK/V/2019

Details and patient eligibility

About

This is a non-randomized clinical trial conducted in a single tertiary hospital which investigates the efficacy of allogeneic adipose-derived mesenchymal stem cells and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation

Full description

Supraspinatus tendon tear is the most common factor causing shoulder pain, mainly resulting in discomfort and functional deficit in individuals over the age of 35. Supraspinatus tendon repair surgery represents one of the most widely performed types of orthopedic operation. Nevertheless, concerns persist regarding tendon-to-bone healing during the postoperative period. Despite advancements in surgical technique, re-tear of a previously repaired supraspinatus tendon is a fairly common complication, especially in a larger size tear. Such repair technique employing suture anchor devices alone has not yet produced functional results demonstrating both anatomical and biomechanical properties. Therefore, tendon tissue engineering using a combination of scaffolds, cells, and growth factors stimulation offers a potential solution as a biological augmentation in tendon repair.

Human amniotic membrane (HAM) has been widely used as a natural scaffold in tissue engineering due to many of its unique properties such as providing growth factors, cytokines and tissue inhibitors of metalloproteinases, adequate mechanical strength, and biocompatibility. Whereas, mesenchymal stem cells (MSCs) constitute one of the adult stem cells that promote replacement and repair of damaged tissue along with normal tissue turnover. These MSCs are seeded to the HAM scaffolds to biologically augment tendon repair, with MSCs acting as cytokines/growth factors to stimulate tissue repair. This approach serves as the foundation to conduct the present study. The investigators aim to investigate the efficacy of using allogeneic adipose-derived MSCs and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation.

Enrollment: 24 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Suffering from complete/total tear of supraspinatus tendon for a duration of fewer than 12 months
• Diagnosis is established based on clinical condition and ultrasonography or MRI examination

Exclusion criteria

• Patients with comorbid diseases: Diabetes Mellitus, Rheumatoid Arthritis, and other inflammatory diseases.
• Patients presenting with other related injuries, such as fractures or dislocation around the shoulder joint.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

Control group (Tendon repair)

Active Comparator group

Description:

The control group will undergo tendon repair procedure only (without augmentation)

Treatment:

Procedure: Tendon repair procedure

Experimental group (Tendon repair augmented with AAdMSC-HAM composite)

Experimental group

Description:

The experimental group will undergo tendon repair procedure augmented with AAdMSC-HAM composite

Treatment:

Procedure: Tendon repair augmented with AAdMSC-HAM composite