Mesenchymal Stem Cells and Amniotic Membrane Composite for Supraspinatus Tendon Repair Augmentation
NCT ID: NCT04670302
Last Updated: 2020-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2019-10-17
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control group (Tendon repair)
The control group will undergo tendon repair procedure only (without augmentation)
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.
Experimental group (Tendon repair augmented with AAdMSC-HAM composite)
The experimental group will undergo tendon repair procedure augmented with AAdMSC-HAM composite
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis is established based on clinical condition and ultrasonography or MRI examination
Exclusion Criteria
* Patients presenting with other related injuries, such as fractures or dislocation around the shoulder joint.
35 Years
75 Years
ALL
Yes
Sponsors
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Dr. Soetomo General Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Heri Suroto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia
Locations
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Dr. Soetomo General Academic Hospital/ Department Orthopaedic & Traumatology Faculty of Medicine Universitas Airlangga
Surabaya, East Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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Heri Suroto, MD, PhD
Role: primary
Other Identifiers
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1208/KEPK/V/2019
Identifier Type: -
Identifier Source: org_study_id