Degenerative ArthritisNCT03000712
Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.
A study testing Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml in people with Degenerative Arthritis and Knee Osteoarthritis, run by R-Bio at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Degenerative Arthritis, Knee Osteoarthritis
- What is being tested?
- Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Nov 2016to 22 May 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Patients who can communicate (exclusion of anyone who cannot understand the questionnaire)
- between 20 years and 80 years of age
- BMI≤30
- Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) Global functional criteria : There is the pain of the knee and radiographic osteophyte and at least one of the following (1) age >50 years (2) Less than 30 minutes of morning stiffness (3) The friction When moving weighted the knee
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- Patients who agree with contraception
- Patients who agree to stop the existing osteoarthritis treatment and to get enough washout periods until medication time
- Patients scheduled for High tibial osteotomy due to medial gonarthrosis
Who cannot join
- patients with osteoporosis
- Preparing for Pregnancy or Pregnant women or lactating mothers.
- Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
- Patients with hypersensitivity to investigator product or investigational product component or those with a history
- Patients who had participated in other clinical trials within 12 weeks prior to this study
- Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
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- Patients who experienced as the knee joint cartilage and stem cell therapy or failure to treat
- Patents who started or changed the physical therapy program established within 2 weeks before the start of the study or during the study(An established physical therapy program may continue for the duration of the trial, provided that it does not change in frequency and intensity)
- Patents included in the following specific risk groups that may influence safety and efficacy assessments at the discretion of the investigator:: septic arthtritis, rheumatic disease, gout, recurrent pseudogout, paget disease, joint fracture, alcaptonuria, acromegaly, hemochromatosis, wilson's disease, primary osteochondrosis, hereditary disorder(ex: hyperkinesia), collagen gene abnormality ,etc
- Patients who have clinically significant severe medical illnesses judged the principal investigator
- Patients who have been diagnosed with malignancy within 5 years before screening (except for patients who were completely remissioned three years before screening criteria)
- Patients who the principal investigator consider inappropriate for the clinical trial due to any other reasons
- Patients who received concomitant contraindications and who have not passed the prescribed wash-out period before participating in the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Open Label, Negative-controlled Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC(Autologous Adipose Tissue Derived Mesenchymal Stem Cells) After High Tibial Osteotomy Compared to Negative Control in the Osteoarthritis Patients.
The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients
Read the detailed description
In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side.
The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.
- Conditions
- Degenerative Arthritis, Knee Osteoarthritis
- Being tested
- Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
- Keywords
- adipose tissue derived mesenchymal stem cell, osteoarthritis, degenerative arthritis, kyung hee university hospital, biostar, Rbio, Osteoarthritis, Knee, High tibial osteotomy, Joint Diseases
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose Tissue derived MSCs 1x10^8cells/3mlBiological
Also called JOINTSTEM
biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy) Receives: Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml |
| No treatment | No intervention | No treatment (after high tibial osteotomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI scan
MRI perform to measure cartilage defect size change from baseline up to 27 weeks
Measured: 24 months
Secondary outcomes (11)
MRI scan
MRI perform to measure cartilage defect size change from baseline up to 15 weeks
Measured: 15, 27 weeks, 18, 24 months
WOMAC score
Change in WOMAC Total score from baseline up to 15, 27 weeks
Measured: 15, 27 weeks, 18, 24 months
WOMAC sub-scale
Change in WOMAC sub-scale from baseline up to 15, 27 weeks
Measured: 15, 27 weeks, 18, 24 months
Kellgren & Lawrence grade
Change in Kellgren \& Lawrence grade from baseline up to 15, 27 weeks
Measured: 15, 27 weeks, 18, 24 months
EQ5D
Change in the score of EQ-5D from baseline up to 15, 27 weeks
Measured: 15, 27 weeks, 18, 24 months
ROM
change from baseline in knee flexion Range of Motion(ROM) at 15,27 weeks by physical examination
Measured: 15, 27 weeks, 18, 24 months
KOOS (Knee Injury & Osteoarthritis Outcome Score)
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 15, 27 weeks, 18, 24 months
PGIC(Patient Global Impression of Change)
The percentage of subjects who were evaluated as improved at 15 weeks and 27 weeks in the patient global impression of change
Measured: 15, 27 weeks, 18, 24 months
PSQI(Pittsburgh Sleep Quality Index)
Change in PSQI from baseline up to 15, 27 weeks
Measured: 15, 27 weeks, 18, 24 months
Biomarkers
Change from baseline in Biomarkers up to 15, 27 weeks
Measured: 15, 27 weeks, 18, 24 months
Incidence of adverse reactions and characteristics associated with investigational product
Measured: 15, 27 weeks, 18, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start2 Nov 2016
- Primary completion22 May 2020
- Study completion22 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Degenerative ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KANGIL KIM, M.D., Ph.D, Principal investigator, KyungHee University Gangdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000712
- Sponsor's protocol ID
- HTO-MSCs
- Status last verified
- Jun 2019
- First submitted
- 18 Dec 2016
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim JH, Kim KI, Yoon WK, Song SJ, Jin W. Intra-articular Injection of Mesenchymal Stem Cells After High Tibial Osteotomy in Osteoarthritic Knee: Two-Year Follow-up of Randomized Control Trial. Stem Cells Transl Med. 2022 Jun 22;11(6):572-585. doi: 10.1093/stcltm/szac023.
PubMed 35674255
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Open Label, Negative-controlled Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC(Autologous Adipose Tissue Derived Mesenchymal Stem Cells) After High Tibial Osteotomy Compared to Negative Control in the Osteoarthritis Patients.
- ClinicalTrials.gov ID
- NCT03000712
- Acronym / sponsor ID
- HTO-MSCs
- Conditions
- Degenerative Arthritis, Knee Osteoarthritis
- Keywords
- adipose tissue derived mesenchymal stem cell, osteoarthritis, degenerative arthritis, kyung hee university hospital, biostar, Rbio, Osteoarthritis, Knee, High tibial osteotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 22 May 2020 (actual)
- Study completion
- 22 May 2020 (actual)
- First posted
- 22 Dec 2016 (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 the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients
Detailed description
In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side.
The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose Tissue derived MSCs | Experimental | Biological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3mlBiological: Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml, 1 time injection(at 1week after high tibial osteotomy) |
| No treatment | No intervention | –No treatment (after high tibial osteotomy) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Patients who can communicate (exclusion of anyone who cannot understand the questionnaire)
- between 20 years and 80 years of age
- BMI≤30
- Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
Key exclusion criteria (13 listed)
- patients with osteoporosis
- Preparing for Pregnancy or Pregnant women or lactating mothers.
- Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), venereal disease research laboratory(VDRL)
- Patients with hypersensitivity to investigator product or investigational product component or those with a history
- Patients who had participated in other clinical trials within 12 weeks prior to this study
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 1x10^8cells/3mlAlso: JOINTSTEMbiological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution | Biological | Autologous Adipose Tissue derived MSCs |
Primary outcome
MRI scan
Time frame: 24 months
MRI perform to measure cartilage defect size change from baseline up to 27 weeks
11 secondary outcomes
MRI scan
Time frame: 15, 27 weeks, 18, 24 months
WOMAC score
Time frame: 15, 27 weeks, 18, 24 months
WOMAC sub-scale
Time frame: 15, 27 weeks, 18, 24 months
Kellgren & Lawrence grade
Time frame: 15, 27 weeks, 18, 24 months
EQ5D
Time frame: 15, 27 weeks, 18, 24 months
ROM
Time frame: 15, 27 weeks, 18, 24 months
KOOS (Knee Injury & Osteoarthritis Outcome Score)
Time frame: 15, 27 weeks, 18, 24 months
PGIC(Patient Global Impression of Change)
Time frame: 15, 27 weeks, 18, 24 months
PSQI(Pittsburgh Sleep Quality Index)
Time frame: 15, 27 weeks, 18, 24 months
Biomarkers
Time frame: 15, 27 weeks, 18, 24 months
Incidence of adverse reactions and characteristics associated with investigational product
Time frame: 15, 27 weeks, 18, 24 months
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 29 Jan 2021.
- Derived from this study: PubMed 35674255Kim JH, Kim KI, Yoon WK, Song SJ, Jin W. Intra-articular Injection of Mesenchymal Stem Cells After High Tibial Osteotomy in Osteoarthritic Knee: Two-Year Follow-up of Randomized Control Trial. Stem Cells Transl Med. 2022 Jun 22;11(6):572-585. doi: 10.1093/stcltm/szac023.
- Individual participant dataSharing planned: No
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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.
KANGIL KIM, M.D., Ph.D principal investigator
KyungHee University Gangdong Hospital
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 1x10^8cells/3ml in people with Degenerative Arthritis and Knee Osteoarthritis, run by R-Bio 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 9 inclusion and 13 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 29 Jan 2021. 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?
MRI scan (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03000712, which also lists 1 linked publication.
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 29 Jan 2021.