Clinical trial NCT04670302: Mesenchymal Stem Cells and Amniotic Membrane Composite for Supraspinatus Tendon Repair Augmentation
Official title: The Efficacy of Using Allogeneic Adipose-derived Mesenchymal Stem Cells and Human Amniotic Membrane (AAdMSC-HAM) Composite for Supraspinatus Tendon Repair Augmentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supraspinatus Tear
Keywords: Supraspinatus rupture
Supraspinatus tear
Tendon repair
Tendon tissue engineering
Amniotic membrane
Mesenchymal stem cells
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2020-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Active range of motion (AROM) pre-surgery
timeFrame: Pre-surgery
measure: Active range of motion (AROM) at 12 months follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Pain pre-surgery
timeFrame: Pre-surgery Outcome
measure: Pain at follow-up 12 months
timeFrame: 12 months
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
timeFrame: Pre-surgery
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) score at follow-up 12 months
timeFrame: 12 months
measure: Constant-Murley Score (CS) pre-surgery
timeFrame: Pre-surgery
measure: Constant-Murley Score (CS) at follow-up 12 months
timeFrame: 12 months
measure: Tear recurrence (re-tear)
timeFrame: Throughout the study duration (12 months), recorded as the first time complained by the patients (i.e. after "n" months).
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Academic Hospital/ Department Orthopaedic & Traumatology Faculty of Medicine Universitas Airlangga
state: East Java
Study officials:
affiliation: Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia
name: Heri Suroto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: