Overview

This trial is active, not recruiting.

Conditions degenerative arthritis, knee osteoarthritis
Treatments jointstem, saline solution
Phase phase 2/phase 3
Sponsor Biostar
Start date July 2015
End date December 2016
Trial size 120 participants
Trial identifier NCT02658344, Jointstem2b3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Autologous Adipose Tissue derived MSCs
jointstem Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml
Jointstem (Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml), 1 time injection
(Placebo Comparator)
Sodium chloride
saline solution Sodium chloride 9mg/ml
Saline solution (Sodium chloride 9mg/ml), 1 time injection

Primary Outcomes

Measure
WOMAC score
time frame: 24 weeks

Secondary Outcomes

Measure
WOMAC 3 subscale
time frame: 24 weeks
KOOS (Knee Injury & Osteoarthritis Outcome Score)
time frame: 24 weeks
SF(Short Form)-36 Score
time frame: 24 weeks
Global assessment of disease activity
time frame: 24 weeks
Overall satisfaction
time frame: 24 weeks
X-ray
time frame: 24 weeks
MRI scan
time frame: 24 weeks
Arthroscopy evaluation
time frame: 24 weeks
Histological evaluation
time frame: 24 weeks
VAS
time frame: 24 weeks
IKDC
time frame: 24 weeks
ROM
time frame: 24 weeks
Quadriceps power
time frame: 24 weeks
effusion
time frame: 24 weeks
Crepitus
time frame: 24 weeks
Ligament laxity
time frame: 24 weeks
Medial joint line tenderness
time frame: 24 weeks
Pes tenderness
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age 18 and older, male and female 2. Patients must consent in writing to participate in the study by signing and dating an informed consent document 3. Diagnosis of osteoarthritis by ACR osteoarthritis of the knee 4. Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4 5. More than Grade 4 (0~10 point numeric scale) pain at least for 12 weeks 6. Diagnosis of osteoarthritis of class Ⅰ~Ⅲ by ACR(American College of Rheumatology Criteria) Global functional criteria 7. Patient who agree with contraception Exclusion Criteria: 1. Preparing for Pregnancy or Pregnant women or lactating mothers. 2. Patients with Body Mass Index (BMI) > 35. 3. 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 4. Patients with serious condition internal medicine disease 5. Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection. 6. Patient with behavioral disorders, cognitive disorders and chronic mental symptoms 7. Patient with significant neurologic or psychiatric disorders 8. Patients who alcohol, drug abuse history 9. Patients who had participated in other clinical trials within 12 weeks prior to this study. 10. Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment. 11. Patients who experienced as the knee joint cartilage and stem cell therapy 12. Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above 13. Patients who penicillin hypersensitivity reactions -

Additional Information

Official title Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ⅱb/Ⅲ Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
Principal investigator KANGIL KIM, M.D., Ph.D
Description JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues 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 improve pain and joint function, and secondary, to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration within six months. The subjects of this therapy were regenerative patients with K&L grade 2~4 aged 18 or older. JOINTSTEM is expected to be used in patients who have significantly damage cartilage due to its cartilage regeneration ability, in addition to its improvement of pain and joint performance. A;sp. Patients who had already undergone knee arthroplasty can delay their additional surgery with the use of JOINTSTEM. For dose who still have their own cartilage, arthroplasty is not an immediate treatment option, and osteoporosis patients who cannot undergo arthroplasty due to their advanced age can receive JOINTSTEM.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Biostar.