Supraspinatus TearNCT04670302
Mesenchymal Stem Cells and Amniotic Membrane Composite for Supraspinatus Tendon Repair Augmentation
A study testing Tendon repair procedure and Tendon repair augmented with AAdMSC-HAM composite in people with Supraspinatus Tear, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Supraspinatus Tear
- What is being tested?
- Tendon repair procedure and Tendon repair augmented with AAdMSC-HAM composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Oct 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Soetomo General Academic Hospital/ Department Orthopaedic & Traumatology Faculty of Medicine Universitas Airlangga
Surabaya, East Java, 60286
Heri Suroto, MD, PhD
About this study
Official title: The Efficacy of Using Allogeneic Adipose-derived Mesenchymal Stem Cells and Human Amniotic Membrane (AAdMSC-HAM) Composite for Supraspinatus Tendon Repair Augmentation
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
Read the 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.
- Conditions
- Supraspinatus Tear
- Being tested
- Tendon repair procedure, Tendon repair augmented with AAdMSC-HAM composite
- Keywords
- Supraspinatus rupture, Supraspinatus tear, Tendon repair, Tendon tissue engineering, Amniotic membrane, Mesenchymal stem cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendon repair procedureProcedure or surgery
Tendon repair procedure:
- Single senior surgeon (HS) will perform mini-open surgery to decompress the acromioplasty and repair the supraspinatus tendon.
- Splicing is achieved by installing screw-type anchors on the insertional footprint of the humeral head greater tuberosity.
- Then, double suturing of the supraspinatus tendon is performed.
Tendon repair augmented with AAdMSC-HAM compositeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Tendon repair) | Active comparator | The control group will undergo tendon repair procedure only (without augmentation) Receives: Procedure: Tendon repair procedure |
| Experimental group (Tendon repair augmented with AAdMSC-HAM composite) | Experimental | The experimental group will undergo tendon repair procedure augmented with AAdMSC-HAM composite Receives: Procedure: Tendon repair augmented with AAdMSC-HAM composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (7)
Pain pre-surgery
Measured by visual analogue scales (VAS). Patients are asked to described their level of pain from the scale 0 to 10 (0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, 7-9 indicating severe pain, and 10 indicating the worst, unbearable pain). The lower scores mean a better pain outcome
Measured: Pre-surgery Outcome
Pain at follow-up 12 months
Measured by visual analogue scales (VAS). Patients are asked to described their level of pain from the scale 0 to 10 (0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, 7-9 indicating severe pain, and 10 indicating the worst, unbearable pain). The lower scores mean a better pain outcome
Measured: 12 months
Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
DASH score is a self-assessment of symptoms and function of the entire upper extremity comprising 30 items. Each item consists of five levels of answers (1=no difficulty/symptoms, 2=mild difficulty/symptoms, 3=moderate difficulty/symptoms, 4=severe difficulty/symptoms, and 5=extreme difficulty (unable to do)/symptoms). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). Greater DASH scores reflect greater disability (worse outcome).
Measured: Pre-surgery
Disabilities of the Arm, Shoulder, and Hand (DASH) score at follow-up 12 months
DASH score is a self-assessment of symptoms and function of the entire upper extremity comprising 30 items. Each item consists of five levels of answers (1=no difficulty/symptoms, 2=mild difficulty/symptoms, 3=moderate difficulty/symptoms, 4=severe difficulty/symptoms, and 5=extreme difficulty (unable to do)/symptoms). The scores are then used to calculate a scale score ranging from 0 (no disability) to 100 (most severe disability). Greater DASH scores reflect greater disability (worse outcome).
Measured: 12 months
Constant-Murley Score (CS) pre-surgery
The scoring system records individual parameters and provides an overall clinical functional assessment. It consists of 4 domains: pain, activities of daily living (ADL), mobility, and power/strength. Pain and ADL are self-assessed, while all other items are assessed by the blinded examiner. A higher score shows a better function (100 as the best), while a lower score shows a worse function (0 as the worst).
Measured: Pre-surgery
Constant-Murley Score (CS) at follow-up 12 months
The scoring system records individual parameters and provides an overall clinical functional assessment. It consists of 4 domains: pain, activities of daily living (ADL), mobility, and power/strength. Pain and ADL are self-assessed, while all other items are assessed by the blinded examiner. A higher score shows a better function (100 as the best), while a lower score shows a worse function (0 as the worst).
Measured: 12 months
Tear recurrence (re-tear)
A systematic review (D'Ambrosi et al., 2019) showed that re-tear rates after rotator cuff repair with scaffolds were 17.97%. We hypothesize that the augmentation using HAM (as scaffold) seeded with AAdMSC would further lower the re-tear rates. We plan to record the recurrence of supraspinatus tendon tear (if any) based on radiographic evaluation with ultrasonography, which will then be confirmed with MRI. Ultrasonography provides an excellent anatomical evaluation of soft tissue which is able to assess any alterations during active locomotion. However, due to its user-dependent nature, we will also confirm the findings with MRI examination. Any grade of re-tear (grade I-III as evaluated by ultrasonography and confirmed with MRI) will be counted in and classified as "re-tear". When the patients do not complain about any symptoms of re-tear, we will record them as "no re-tear".
Measured: Throughout the study duration (12 months), recorded as the first time complained by the patients (i.e. after "n" months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraspinatus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Heri Suroto, MD, PhD, Principal investigator, Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670302
- Sponsor's protocol ID
- 1208/KEPK/V/2019
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Using Allogeneic Adipose-derived Mesenchymal Stem Cells and Human Amniotic Membrane (AAdMSC-HAM) Composite for Supraspinatus Tendon Repair Augmentation
- ClinicalTrials.gov ID
- NCT04670302
- Acronym / sponsor ID
- 1208/KEPK/V/2019
- Conditions
- Supraspinatus Tear
- Keywords
- Supraspinatus rupture, Supraspinatus tear, Tendon repair, Tendon tissue engineering, Amniotic membrane, Mesenchymal stem cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (Tendon repair) | Active comparator | Procedure: Tendon repair procedureThe control group will undergo tendon repair procedure only (without augmentation) |
| Experimental group (Tendon repair augmented with AAdMSC-HAM composite) | Experimental | Procedure: Tendon repair augmented with AAdMSC-HAM compositeThe experimental group will undergo tendon repair procedure augmented with AAdMSC-HAM composite |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendon repair procedureTendon 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 or surgery | Control group (Tendon repair) |
| Tendon repair augmented with AAdMSC-HAM compositeAfter 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. | Procedure or surgery | Experimental group (Tendon repair augmented with AAdMSC-HAM composite) |
Primary outcome
Active range of motion (AROM) pre-surgery
Time frame: Pre-surgery
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.
Active range of motion (AROM) at 12 months follow-up
Time frame: 12 months
Shoulder: flexion, extension, abduction, adduction, external rotation, internal rotation. The tests are performed by two blinded assessor, and expressed in degrees.
7 secondary outcomes
Pain pre-surgery
Time frame: Pre-surgery Outcome
Pain at follow-up 12 months
Time frame: 12 months
Disabilities of the Arm, Shoulder, and Hand (DASH) score pre-surgery
Time frame: Pre-surgery
Disabilities of the Arm, Shoulder, and Hand (DASH) score at follow-up 12 months
Time frame: 12 months
Constant-Murley Score (CS) pre-surgery
Time frame: Pre-surgery
Constant-Murley Score (CS) at follow-up 12 months
Time frame: 12 months
Tear recurrence (re-tear)
Time frame: Throughout the study duration (12 months), recorded as the first time complained by the patients (i.e. after "n" months).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heri Suroto, MD, PhD principal investigator
Cell and Tissue Bank-Regenerative Medicine, Dr. Soetomo General Academic Hospital, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendon repair procedure and Tendon repair augmented with AAdMSC-HAM composite in people with Supraspinatus Tear, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heri Suroto, MD, PhD (62 31 5038335, hsuroto2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion (AROM) pre-surgery (time frame: Pre-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.