Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ⅱb Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
1 other identifier
interventional
24
1 country
2
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Knee Osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2015
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 3, 2015
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 5, 2019
June 1, 2019
1.3 years
August 3, 2015
June 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
WOMAC score
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
24 weeks
Secondary Outcomes (18)
WOMAC 3 subscale
24 weeks
KOOS (Knee Injury & Osteoarthritis Outcome Score)
24 weeks
SF(Short Form)-36 Score
24 weeks
Global assessment of disease activity
24 weeks
Overall satisfaction
24 weeks
- +13 more secondary outcomes
Study Arms (2)
Jointstem
EXPERIMENTALAutologous Adipose Tissue derived MSCs
Saline solution
PLACEBO COMPARATORSodium chloride
Interventions
Jointstem (Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml), 1 time injection
Saline solution (Sodium chloride 9mg/ml), 1 time injection
Eligibility Criteria
You may qualify if:
- Age 18 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 osteoarthritis by ACR osteoarthritis of the knee
- Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- More than Grade 4 (0\~10 point numeric scale) pain at least for 12 weeks
- Diagnosis of osteoarthritis of class Ⅰ\~Ⅲ by ACR(American College of Rheumatology Criteria) Global functional criteria
- Patient who agree with contraception
You may not qualify if:
- Preparing for Pregnancy or Pregnant women or lactating mothers.
- Patients with Body Mass Index (BMI) \> 35.
- Patients with other disease including
- : Septic arthritis, Rheumatoid or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder
- Patients with serious condition internal medicine disease
- Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection.
- Patient with behavioral disorders, cognitive disorders and chronic mental symptoms
- Patient with significant neurologic or psychiatric disorders
- Patients who alcohol, drug abuse 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.
- Patients who experienced as the knee joint cartilage and stem cell therapy
- Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
- Patients who penicillin hypersensitivity reactions -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Biolead
Study Sites (2)
KyungHee University Gangdong Hospital
Seoul, 134-727, South Korea
GangNam Severance Hospital
Seoul, 135-720, South Korea
Related Publications (1)
Lee WS, Kim HJ, Kim KI, Kim GB, Jin W. Intra-Articular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis: A Phase IIb, Randomized, Placebo-Controlled Clinical Trial. Stem Cells Transl Med. 2019 Jun;8(6):504-511. doi: 10.1002/sctm.18-0122. Epub 2019 Mar 5.
PMID: 30835956RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KANGIL KIM, M.D., Ph.D
KyungHee University Gangdong Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2015
First Posted
January 18, 2016
Study Start
July 1, 2015
Primary Completion
November 1, 2016
Study Completion
December 1, 2016
Last Updated
June 5, 2019
Record last verified: 2019-06