This trial is active, not recruiting.

Condition osteoarthritis knee
Treatment adipose-derived mesenchymal stem cells
Phase phase 1
Sponsor Steminent Biotherapeutics Inc.
Start date June 2015
End date February 2017
Trial size 4 participants
Trial identifier NCT02544802, SB-VGH-201102


The purpose of this study is to evaluate the safety and preliminary efficacy of autologous adipose-derived mesenchymal stem cells (ADMSCs) treatment for patients with primary osteoarthritis knee. Three intra-articular injections of autologous ADMSCs will be performed to subjects at a weekly interval.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection
adipose-derived mesenchymal stem cells

Primary Outcomes

Safety of intra-articular injection of autologous ADMSCs by incidence of adverse events and alterations in vital signs, blood chemistry profiles, complete blood count, urinalysis, and also the physical examination of the knees.
time frame: 12 months

Secondary Outcomes

Clinical assessment of visual analogue scale (VAS)
time frame: 12 months
Clinical assessment of Short Form 36 questionnaire (SF-36)
time frame: 12 months
Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
time frame: 12 months
Clinical assessment of Hospital for Special Surgery (HSS) Knee Score
time frame: 12 months
Clinical imaging assessment of knee X-ray
time frame: 12 months
Clinical imaging assessment of MRI of the knee
time frame: 12 months

Eligibility Criteria

Male or female participants from 50 years up to 70 years old.

Inclusion Criteria: 1. Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray. 2. Subject's pain score is 8-13 points (Lequesne's index). 3. Ages between 50-70 years. 4. Signed informed consent from the subject. 5. Female subjects should be post-menopausal women Exclusion Criteria: 1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV. 2. Subject not suitable for liposuction surgery. 3. Subject with hypersensitivity/allergy to anesthetic. 4. Subject's creatinine values higher than 1.6mg/dl. 5. Subject with body mass index, BMI over 30. 6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. 7. Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. 8. Subject enrolled in any other cell therapy studies within the past 30 days. 9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. 10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. 11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Additional Information

Official title Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Steminent Biotherapeutics Inc..