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

NCT04670302 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-12-17

No results posted yet for this study

Summary

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

Conditions

  • Supraspinatus Tear

Interventions

PROCEDURE

Tendon repair procedure

Tendon repair procedure: 1. Single senior surgeon (HS) will perform mini-open surgery to decompress the acromioplasty and repair the supraspinatus tendon. 2. Splicing is achieved by installing screw-type anchors on the insertional footprint of the humeral head greater tuberosity. 3. Then, double suturing of the supraspinatus tendon is performed.

PROCEDURE

Tendon repair augmented with AAdMSC-HAM composite

After double suturing of the supraspinatus tendon, the composite comprising freeze-dried HAM (2 cm x 2 cm x 0.002 cm) and AAdMSC (20 million cells) is placed on the upper surface of the splice and fixed with stitches at all four corners.

Sponsors & Collaborators

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Heri Suroto, MD, PhD · Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04670302 on ClinicalTrials.gov