Mesenchymal Stem Cell Treatment for Primary Osteoarthritis Knee

Steminent Biotherapeutics

Status and phase

Completed

Phase 1

Conditions

Osteoarthritis Knee

Treatments

Drug: Adipose-Derived Mesenchymal Stem Cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT02544802

SB-VGH-201102

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

50 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has bilateral Kellgren and Lawrence grade II-III primary osteoarthritis as determined by X-ray.
Subject's pain score is 8-13 points (Lequesne's index).
Ages between 50-70 years.
Signed informed consent from the subject.
Female subjects should be post-menopausal women

Exclusion criteria

Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV.
Subject not suitable for liposuction surgery.
Subject with hypersensitivity/allergy to anesthetic.
Subject's creatinine values higher than 1.6mg/dl.
Subject with body mass index, BMI over 30.
Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
Subject has undergone surgery on either side of knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
Subject enrolled in any other cell therapy studies within the past 30 days.
Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.