Clinical trial NCT02544802: Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee
Official title: Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis Knee
Lead sponsor: Steminent Biotherapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-09
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Clinical assessment of visual analogue scale (VAS)
timeFrame: 12 months
measure: Clinical assessment of Short Form 36 questionnaire (SF-36)
timeFrame: 12 months
measure: Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 12 months
measure: Clinical assessment of Hospital for Special Surgery (HSS) Knee Score
timeFrame: 12 months
measure: Clinical imaging assessment of knee X-ray
timeFrame: 12 months
measure: Clinical imaging assessment of MRI of the knee
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: