Degenerative ArthritisNCT04821102
Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Administration
A study testing JOINTSTEM and Saline in people with Degenerative Arthritis and Knee Arthritis, run by R-Bio at 1 site in South Korea.
Trial summary
The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Degenerative Arthritis, Knee Arthritis
- What is being tested?
- JOINTSTEM and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20 and older, male and female
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
- Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
- Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline
- clinical and inspectional opinion
Show all 11Show fewer
- clinical and radiographic opinion
- clinical opinion
- Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
- Patient who has WOMAC score ≥ 1000 at Screening
- No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening
Who cannot join
- Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods
- Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
- Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
- Not allowed to use hormonal contraceptives
- Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
- Pregnant women or lactating mothers
Show all 36Show fewer
- Patients with Body Mass Index (BMI) > 35
- Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
- Patients with other disease including
- Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
- Patients who are diagnosed with malignant tumor in the past or present
- Patients who have clinically significant diseases including
- Cardiac disorder (Myocardial infarction, Coronary artery bypass graft, Arrhythmia and other severe Cardiac disorder etc.)
- Resistant hypertension (systolic blood pressure > 160mmHg or diastolic pressure > 100mmHg at Screening)
- Kidney disease (Chronic renal failure, Glomerulonephritis etc.)
- Liver disease (Hepatocirrhosis, Fatty liver, acute or chronic liver disease etc.)
- Endocrinopathy (Thyroiditis, Diabetes insipidus, Cushing disease etc.)
- Patients who have significant lab abnormalities
- Patients who have severe pain in other areas that can affect the judgement of knee joint symptom
- Patients who underwent any arthroscopic surgery on the injection site within 6 months of the screening visit date, or scheduled to perform any surgery during the clinical trial period
- Patients who received any drug by intra-articular injection(hyaluronic acid or steroid etc.) for treatment within 6 months prior to Screening
- Patients who experienced as stem cell therapy or blood product injection(PRP, Prolo therapy etc.)
- Patients who received treatment within 14 days prior to Screening including(But, patients who had wash-out-period can participate in this study)
- Take medicines including composition of Glucosamine, Chondretin sulphate and Diacerhein etc.
- Take phytotherapeutic agent or Chinese medicine for osteoarthritis
- Take antiinflammatory analgesic drug, NSAIDs (prescription/nonprescription pharmaceuticals) etc. (Patients who have 3 days of wash-out-period after they took acetaminophen can participate in the study)
- Take oral steroids
- Patients with penicillin hypersensitivity reactions
- Patients with skin diseases or infections in the area of the injection site
- Patients who have abnormal flail over grade 2 flail knee test of anterior to posterior and varus/valgus lesion at physical examination
- Patients who have difficulty in taking MRI because of metal materials (cardiac pacemaker or clip of cerebral artery etc.) in their body or claustrophobia -but, patients with metal materials that are not affected by magnetic field can participate in this study
- Patients who have difficulty in liposuction or local anesthesia
- Patients who have alcohol, drug abuse history
- Patients who have severe neurologic and psychiatric disorders that affect clinical trials
- Patients who had participated in other clinical trials within 12 weeks prior to this study
- Patients who the principal investigator considers 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
Bethesda Hospital
Yangsan, 50576
Chang-Min Lee, M.D., Ph.D., 055-781-9722, oschangmin@naver.com
Ju-Yeun Lee, 055-781-9722, radio00t@naver.com
About this study
Official title: Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy in Patients With K-L Grade III Knee Osteoarthritis After JOINTSTEM Administration
The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3
Read the detailed description
JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.
The subjects of this therapy were patients with K\&L grade 3 aged 20 or older.
This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 21 patients will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 placebo control). After each patient completes 12-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
- Conditions
- Degenerative Arthritis, Knee Arthritis
- Being tested
- JOINTSTEM, Saline
- Keywords
- Stem cell, Adipose tissue derived mesenchymal stem cell, Osteoarthritis, degenerative arthritis, Biostar, Rbio
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JOINTSTEMBiological
Also called Autologous Adipose Tissue derived MSCs
JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection under ultrasonic guided
SalineDrug
saline, 1 time injection under ultrasonic guided
| Study group | Role | What they receive |
|---|---|---|
| JOINTSTEM | Experimental | Autologous Adipose Tissue derived MSCs Receives: Biological: JOINTSTEM |
| Saline | Placebo comparator | saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthroscopy
Change of damaged cartilage defects after 48 weeks from IP administration, compared to Baseline (Experimental group vs Control group)
Measured: 48 Weeks
Secondary outcomes (8)
WOMAC total score
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) total scores from baseline (Experimental group vs Control group)
Measured: 12 weeks, 24 weeks, 48 weeks
WOMAC subscale score
Change of Western Ontario and McMaster Universities (WOMAC) subscale score (3 sub-scales: Pain, stiffness, and physical function of the knee) from baseline (Experimental group vs Control group)
Measured: 12 weeks, 24 weeks, 48 weeks
VAS score
Change of Visual Analog Scale (VAS) from baseline (Experimental group vs Control group) Pain of knee will be measured by the 100mm VAS Score range is from 0mm(no pain) to 100mm(severe pain) Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)
Measured: 12 weeks, 24 weeks, 48 weeks
RAND-36
Change of The RAND-36 Measure of Health-Related Quality of Life (RAND-36) score from baseline (Experimental group vs Control group) Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
Measured: 12 weeks, 24 weeks, 48 weeks
IKDC
Change of International Knee Documentation Committee (IKDC) score from baseline (Experimental group vs Control group) The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Measured: 12 weeks, 24 weeks, 48 weeks
Biopsy
Change of Biopsy from baseline (Experimental group vs Control group)
Measured: 48 Weeks
Use of rescue medication
Frequency and total amount of rescue medication administration will be measured.
Measured: 4 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Kellgren-Lawrence grade
Change from baseline in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
Measured: 24 Weeks, 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Jul 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R-Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CHANGMIN LEE, M.D.,Ph.D., Principal investigator, Bethesda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821102
- Sponsor's protocol ID
- BS-JS-IIT1
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy in Patients With K-L Grade III Knee Osteoarthritis After JOINTSTEM Administration
- ClinicalTrials.gov ID
- NCT04821102
- Acronym / sponsor ID
- BS-JS-IIT1
- Conditions
- Degenerative Arthritis, Knee Arthritis
- Keywords
- Stem cell, Adipose tissue derived mesenchymal stem cell, Osteoarthritis, degenerative arthritis, Biostar, Rbio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- R-BioIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Mar 2021 (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.
The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3
Detailed description
JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
It primarily aims to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration.
The subjects of this therapy were patients with K\&L grade 3 aged 20 or older.
This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 21 patients will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 placebo control). After each patient completes 12-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JOINTSTEM | Experimental | Biological: JOINTSTEMAutologous Adipose Tissue derived MSCs |
| Saline | Placebo comparator | Drug: Salinesaline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 20 and older, male and female
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
- Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
- Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline
Key exclusion criteria (36 listed)
- Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods
- Pregnant women or lactating mothers
- Patients with Body Mass Index (BMI) > 35
- Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
- Patients with other disease including
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 |
|---|---|---|
| JOINTSTEMAlso: Autologous Adipose Tissue derived MSCsJOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection under ultrasonic guided | Biological | JOINTSTEM |
| Salinesaline, 1 time injection under ultrasonic guided | Drug | Saline |
Primary outcome
Arthroscopy
Time frame: 48 Weeks
Change of damaged cartilage defects after 48 weeks from IP administration, compared to Baseline (Experimental group vs Control group)
8 secondary outcomes
WOMAC total score
Time frame: 12 weeks, 24 weeks, 48 weeks
WOMAC subscale score
Time frame: 12 weeks, 24 weeks, 48 weeks
VAS score
Time frame: 12 weeks, 24 weeks, 48 weeks
RAND-36
Time frame: 12 weeks, 24 weeks, 48 weeks
IKDC
Time frame: 12 weeks, 24 weeks, 48 weeks
Biopsy
Time frame: 48 Weeks
Use of rescue medication
Time frame: 4 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Kellgren-Lawrence grade
Time frame: 24 Weeks, 48 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- 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.
CHANGMIN LEE, M.D.,Ph.D. principal investigator
Bethesda 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 JOINTSTEM and Saline in people with Degenerative Arthritis and Knee Arthritis, 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 11 inclusion and 36 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 28 Sep 2022. 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. Some participants in this study may receive a placebo. 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 CHANGMIN LEE, M.D.,Ph.D. (055-781-9722, oschangmin@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthroscopy (time frame: 48 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 28 Sep 2022.