Rotator Cuff DiseaseNCT02474342
Autologous Adipose Tissue Derived Mesenchymal Stem Cells for Rotator Cuff Disease
A study testing Autologous Adipose Tissue Derived MSCs Transplantation in people with Rotator Cuff Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Disease
- What is being tested?
- Autologous Adipose Tissue Derived MSCs Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2015to 7 Nov 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 19 years of age and older.
- Patients who have unilateral shoulder pain.
- Patients who have had pain at least for 3 months and do not respond to conservative treatment.
- Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
Who cannot join
- Participants who met a single condition were excluded from the study
- Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
- Patients who have a history of shoulder trauma including dislocation, subluxation, and fracture, breast cancer, or surgery around shoulder, neck and upper back within 6 months prior to this enrollment.
- Patients who have a full-thickness rotator cuff tear
- Patients who have radiological findings of malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities decreasing the subacromial space
- Patients with symptomatic cervical spine disorders
Show all 18Show fewer
- Patients with concurrent bilateral shoulder pain
- Patients with adhesive capsulitis, acromioclavicular arthropathy, polyarthritis, infectious arthritis, rheumatoid arthritis or diagnosed fibromyalgia
- Patients with neurological deficit
- Pregnant women or lactating mothers
- Fertile woman of childbearing potential not willing to use adequate contraception for the study duration
- Patients taking anticoagulants
- Patients who are positive serology for human immunodeficiency (HIV), hepatitis B (HBV) or hepatitis C (HCV) and syphilis
- Patients with serious condition which can affect this study such as severe cardiovascular diseases, renal diseases, liver diseases, endocrine diseases, and cancers
- Patients who are difficulty participating in data collection due to communication problem and serious mental illness
- Patients are unable to come into the clinic for regular follow-up
- Patients who had participated in other clinical trials within 3 months prior to this study.
- Patients who the principal investigator considered inappropriate for the clinical trial due to any other reasons than those listed above.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul
About this study
Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.
- Conditions
- Rotator Cuff Disease
- Being tested
- Autologous Adipose Tissue Derived MSCs Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Tissue Derived MSCs TransplantationBiological
- Study drugs: Autologous adipose tissue derived MSCs
- Injection dosage and volume of the study drugs:
- Low dose: 1x10e7 cells/3mL
- Number of injections : only once during the study period
- Device: Ultrasound
- Injection technique: Injection into the lesion by investigator
Autologous Adipose Tissue Derived MSCs TransplantationBiological
- Study drugs: Autologous adipose tissue derived MSCs
- Injection dosage and volume of the study drugs:
- Mid dose: 5x10e7 cells/3mL
- Number of injections : only once during the study period
- Device: Ultrasound
- Injection technique: Injection into the lesion by investigator
Autologous Adipose Tissue Derived MSCs TransplantationBiological
- Study drugs: Autologous adipose tissue derived MSCs
- Injection dosage and volume of the study drugs:
- High dose: 1x10e8 cells/3mL
- Number of injections : only once during the study period
- Device: Ultrasound
- Injection technique: Injection into the lesion by investigator
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Not described Receives: Biological: Autologous Adipose Tissue Derived MSCs Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPADI(Shoulder pain and disability index)Score
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Measured: 24 weeks
Secondary outcomes (5)
Constant-Murley score
The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100.
Measured: 24 weeks
Visual Analog Scale_pain in motion
Measured: 24 weeks
Changes in the size of rotator cuff tears determined by MRI
Measured: 24 weeks
Changes in the size of rotator cuff tears determined by arthroscopy
Measured: 24 weeks
Adverse event
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start7 Jul 2015
- Primary completionNov 2016
- Study completion7 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Jo, Seoul National University Hospital
- Investigators
- Chris H. Jo, M.D., Ph.D, Principal investigator, Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474342
- Sponsor's protocol ID
- BRM-15-01
- Status last verified
- May 2016
- First submitted
- 2 Jun 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Rotator Cuff Disease
- ClinicalTrials.gov ID
- NCT02474342
- Acronym / sponsor ID
- BRM-15-01
- Conditions
- Rotator Cuff Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- 7 Nov 2016 (actual)
- First posted
- 17 Jun 2015 (estimated)
- 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.
The purpose of this study is to evaluate safety and efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells injection in patient with Rotator Cuff disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Biological: Autologous Adipose Tissue Derived MSCs Transplantation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 19 years of age and older.
- Patients who have unilateral shoulder pain.
- Patients who have had pain at least for 3 months and do not respond to conservative treatment.
- Patients who have a partial-thickness rotator cuff tear confirmed with magnetic resonance imaging (MRI) or ultrasonography (US).
Key exclusion criteria (18 listed)
- Participants who met a single condition were excluded from the study
- Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
- Patients who have a history of shoulder trauma including dislocation, subluxation, and fracture, breast cancer, or surgery around shoulder, neck and upper back within 6 months prior to this enrollment.
- Patients who have a full-thickness rotator cuff tear
- Patients who have radiological findings of malignancy, osteoarthritis of the glenohumeral joint, and skeletal abnormalities decreasing the subacromial space
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 |
|---|---|---|
| Autologous Adipose Tissue Derived MSCs Transplantation1. Study drugs: Autologous adipose tissue derived MSCs 2. Injection dosage and volume of the study drugs: * Low dose: 1x10e7 cells/3mL 3. Number of injections : only once during the study period 4. Device: Ultrasound 5. Injection technique: Injection into the lesion by investigator | Biological | Autologous Adipose Tissue derived MSCs |
| Autologous Adipose Tissue Derived MSCs Transplantation1. Study drugs: Autologous adipose tissue derived MSCs 2. Injection dosage and volume of the study drugs: * Mid dose: 5x10e7 cells/3mL 3. Number of injections : only once during the study period 4. Device: Ultrasound 5. Injection technique: Injection into the lesion by investigator | Biological | Autologous Adipose Tissue derived MSCs |
| Autologous Adipose Tissue Derived MSCs Transplantation1. Study drugs: Autologous adipose tissue derived MSCs 2. Injection dosage and volume of the study drugs: * High dose: 1x10e8 cells/3mL 3. Number of injections : only once during the study period 4. Device: Ultrasound 5. Injection technique: Injection into the lesion by investigator | Biological | Autologous Adipose Tissue derived MSCs |
Primary outcome
SPADI(Shoulder pain and disability index)Score
Time frame: 24 weeks
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
5 secondary outcomes
Constant-Murley score
Time frame: 24 weeks
Visual Analog Scale_pain in motion
Time frame: 24 weeks
Changes in the size of rotator cuff tears determined by MRI
Time frame: 24 weeks
Changes in the size of rotator cuff tears determined by arthroscopy
Time frame: 24 weeks
Adverse event
Time frame: 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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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.
Chris H. Jo, M.D., Ph.D principal investigator
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Adipose Tissue Derived MSCs Transplantation in people with Rotator Cuff Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 18 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: finished, as of the sponsor's last update on 7 Mar 2017. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPADI(Shoulder pain and disability index)Score (time frame: 24 weeks). 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 7 Mar 2017.