The Efficacy of Using Allogeneic Adipose-derived Mesenchymal Stem Cells and Human Amniotic Membrane (AAdMSC-HAM) Composite for Supraspinatus Tendon Repair Augmentation
Sponsor study identifier
interventional
24
1 country
1
Study Start
October 17, 2019
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 17, 2019
Actual (reported)December 8, 2020
Actual (reported)December 17, 2020
Actual (reported)December 31, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Active range of motion (AROM) pre-surgery
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.
Pre-surgery
Active range of motion (AROM) at 12 months follow-up
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.
12 months
Pain pre-surgery
Pre-surgery Outcome
Pain at follow-up 12 months
12 months
Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
Pre-surgery
Disabilities of the Arm, Shoulder, and Hand (DASH) score at follow-up 12 months
12 months
Constant-Murley Score (CS) pre-surgery
Pre-surgery
The control group will undergo tendon repair procedure only (without augmentation)
The experimental group will undergo tendon repair procedure augmented with AAdMSC-HAM composite
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.
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.
Dr. Soetomo General Academic Hospital/ Department Orthopaedic & Traumatology Faculty of Medicine Universitas Airlangga
Surabaya, East Java, 60286, Indonesia
Heri Suroto, MD, PhD
Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia
First Submitted
December 8, 2020
First Posted
December 17, 2020
Study Start
October 17, 2019
Actual (reported)Primary Completion
December 31, 2021
Estimated (date passed)Treatment of the Biceps With Concomitant Supraspinatus Tears
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 17, 2020
Record last verified: 2020-12
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Source: ClinicalTrials.gov.
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