A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
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ClinicalTrials.gov Identifier: NCT04368806 |
Recruitment Status :
Recruiting
First Posted : April 30, 2020
Last Update Posted : February 8, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis, Knee | Drug: JointStem Other: Placebo Control | Phase 2 Phase 3 |
Study Procedures:
- Visit 1 (Week -7) - Screening
- Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration)
- Visit 3 (Week 0) - Treatment (Intra-articular injection)
- Visit 4 (Week 4) - 4 weeks follow-up
- Visit 5 (Week 12) - 12 weeks follow-up
- Visit 6 (Week 24) - 24 weeks follow-up
- Visit 7 (Week 36) - 36 weeks follow-up
- Visit 8 (Week 48) - 48 weeks follow-up (End of Study)
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis |
Actual Study Start Date : | May 26, 2021 |
Estimated Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | December 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)
|
Drug: JointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC) |
Placebo Comparator: Placebo
Normal Saline with Autologous Serum
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Other: Placebo Control
Normal Saline with autologous Serum |
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score [ Time Frame: Baseline and Week 48 ]Change from baseline in WOMAC function score at Week 48
- Visual Analog Scale (VAS) score [ Time Frame: Baseline and Week 48 ]Change from baseline on Visual Analog Scale (VAS) score at Week 48
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function) [ Time Frame: Week 12, 24 and 36 ]Change from baseline in WOMAC subscale (Function) score at Week 12, 24, and 36
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Pain) [ Time Frame: Week 12, 24, 36, and 48 ]Change from baseline in WOMAC subscale (Pain) score at Week 12, 24, 36, and 48
- Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score [ Time Frame: Week 12, 24, 36, and 48 ]Change from baseline in total WOMAC score at Week 12, 24, 36, and 48
- Visual Analog Scale (VAS) score [ Time Frame: Week 12, 24 and 36 ]Change from baseline in VAS score at Week 12, 24 and 36
- International Knee Documentation Committee (IKDC) score [ Time Frame: Week 12, 24, 36, and 48 ]Change from baseline in IKDC score at Week 12, 24, 36, and 48
- 36-Item Short Form health survey questionnaires (SF-36) score [ Time Frame: Week12, 24, 36, and 48 ]Change from baseline in SF-36 score at Week 12, 24, 36, and 48
- Cartilage defect area changes in knee joint [ Time Frame: Week 48 ]Change from baseline in cartilage defect area changes to the knee joint determined by MRI at Week 48
- Kellgren-Lawrence grade [ Time Frame: Week 48 ]Change from baseline in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
- Number and amount of rescue medication use [ Time Frame: Week 12, 24, 36, and 48 ]The number and amount of rescue medication use at Week 12, 24, 36, and 48

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)
- Subject who has ≥ 34 on WOMAC function score at Screening and Baseline
- Subject who has knee pain ≥ 50 mm for one kmee and ≤ 40 mm for the other knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline
- Subject who has radiographic evidence of grade 3 osteoarthritis in one knee and grade 1 or 2 in the other knee based on the Kellgren and Lawrence radiographic criteria.
- Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with non-operative treatment options
- Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study
- Subject who is willing and able to give written informed consent for participation in the study
Exclusion Criteria:
- Subject who has Body Mass Index (BMI) > 35 kg/m2
- Subject judged by the investigator to have a history of clinically significant disease
- Subject who has any of following clinically significant disease
- Autoimmune diseases
- Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease
- Genetic diseases (hyperkinesia, collagen gene abnormality, etc.)
- Inflammatory joint disorders (e.g. rheumatoid inflammation)
- Infectious joint disorders (e.g. septic arthritis)
- Other joint disorders (e.g. gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis)
- Subject who has any history of cancer or currently receiving treatment for a current cancer diagnosis
- Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis)
- Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening
- Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening
- Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening
- Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 12 months prior to Screening
- Subject who has history of stem cell therapy
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Subject who have significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
- Serum ALT and AST > 2 x upper limit of normal
- Serum creatinine out of normal range
- PT/INR out of normal range
- Hemoglobin < 10 g/dL for female subject and hemoglobin < 11 g/dL for male subject
- Platelets out of normal range
- Subject for whom the investigator judges the lipoaspiration can cause any problem
- Subject who has history of local anesthetic allergy
- Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.)
- Subject who is an active drug/alcohol abuser
- Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method)
- Subject who is enrolled in any other clinical trials within 3 months from Screening
- Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline)
- Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368806
Contact: Hugh Lee | 301-540-2600 | hughlee@kcrnresearch.com | |
Contact: Christine Lee | 301-540-2600 | christinelee@kcrnresearch.com |
United States, California | |
TriWest Research Associates | Recruiting |
El Cajon, California, United States, 92020 | |
Contact: Louis J. Levy Jr., M.D. 619-334-4735 llevy@triwestresearch.com | |
Contact: David C. Ruiz, Phlebotomist 619-334-4735 dcampos@triwestresearch.com | |
BioSolutions Clinical Research Center | Recruiting |
La Mesa, California, United States, 91942 | |
Contact: Peter B. Hanson, M.D. 619-637-0770 drhanson@biosolutionresearch.com | |
Contact: Tamara Packard, L.V.N. 619-637-0770 tamara@biosolutionresearch.com | |
Neurovations Research | Recruiting |
Napa, California, United States, 94558 | |
Contact: Eric Grigsby, M.D. 707-252-9666 eg@neurovations.com | |
Contact: Louiza Khedim 707-252-9606 Louiza@neurovations.com | |
Source Healthcare | Recruiting |
Santa Monica, California, United States, 90403 | |
Contact: Timothy T. Davis, M.D. 310-574-2777 tdavis@sourcehealthcare.com | |
Contact: Afrida Sara, B.S. 310-574-2777 afridasara@g.ucla.edu | |
United States, District of Columbia | |
International Spine Pain, and Performance Center | Recruiting |
Washington, District of Columbia, United States, 20006 | |
Contact: Mehul Desai, M.D., M.P.H. 202-851-6845 drdesai@isppcenter.com | |
Contact: Sidrah Sheikh, B.A. 202-808-8295 ssheikh@isppcenter.com | |
United States, New Jersey | |
Rothman Orthopaedic Institute | Recruiting |
Egg Harbor Township, New Jersey, United States, 08234 | |
Contact: Bradford S. Tucker, M.D. 844-438-1354 bradford.tucker@rothmanortho.com | |
Contact: Mitchee K. Freedman, D.O. 844-438-1354 lm5656@comcast.net | |
United States, New York | |
Hospital for Special Surgery | Recruiting |
New York, New York, United States, 10021 | |
Contact: Sabrina M. Strickland, M.D. 212-606-1000 | |
Contact: Connor F. Fletcher 212-606-1000 Cff43@cornell.edu |
Responsible Party: | Nature Cell Co. Ltd. |
ClinicalTrials.gov Identifier: | NCT04368806 |
Other Study ID Numbers: |
JS-OAP3-US01 |
First Posted: | April 30, 2020 Key Record Dates |
Last Update Posted: | February 8, 2023 |
Last Verified: | February 2023 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |