Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

Phase 1

Completed

• Conditions: Osteoarthritis Knee
• Interventions: Drug: Adipose-Derived Mesenchymal Stem Cells

• Registration Number: NCT02544802
• Lead Sponsor: Steminent Biotherapeutics Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-09-06
• Study First Posted: 2015-09-09
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADMSCs	Adipose-Derived Mesenchymal Stem Cells	Three intra-articular injections of ADMSCs at the dose of 8\~10x10\^6 cells/injection

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan