Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

Osteoarthritis Knee Clinical Trial

Official title:

Treatment of Primary Osteoarthritis of the Knee Joint With Autologous Mesenchymal Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02544802
• Other study ID #: SB-VGH-201102
• Status: Completed
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: January 31, 2019

Study information

• Verified date: October 2022
• Source: Steminent Biotherapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Adipose-Derived Mesenchymal Stem Cells

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Steminent Biotherapeutics Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical assessment of visual analogue scale (VAS)		12 months
Secondary	Clinical assessment of Short Form 36 questionnaire (SF-36)		12 months
Secondary	Clinical assessment of Western Ontario and McMaster Universities Arthritis Index (WOMAC)		12 months
Secondary	Clinical assessment of Hospital for Special Surgery (HSS) Knee Score		12 months
Secondary	Clinical imaging assessment of knee X-ray		12 months
Secondary	Clinical imaging assessment of MRI of the knee		12 months