Trial | NCT02544802  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    4
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.
Study Started
Jun 30
2015
Primary Completion
Jan 31
2019
Study Completion
Jan 31
2019
Last Update
Oct 28
2022

Drug Adipose-Derived Mesenchymal Stem Cells

ADMSCs Experimental

Three intra-articular injections of ADMSCs at the dose of 8~10x10^6 cells/injection

Criteria 

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.
No Results Posted