Trials / Completed
CompletedNCT03000712
Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.
Single-center, Randomized, Open Label, Negative-controlled Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC(Autologous Adipose Tissue Derived Mesenchymal Stem Cells) After High Tibial Osteotomy Compared to Negative Control in the Osteoarthritis Patients.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- R-Bio · Industry
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of intra-articular injection of autologous adipose tissue derived mesenchymal stem cells compared after high tibial osteotomy to negative control in the osteoarthritis patients
Detailed description
In this clinical trial, the investigational product is administered intra-articularly at 1 week after high tibial osteotomy in a patient with degenerative arthritis of the medial side. The investigational product is autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissue and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection. It primarily aims to regenerate cartilage, to improve pain and joint function. The intra-articular injection of the investigational product is expected to stimulate the regeneration and growth of cartilage, and to innovatively improve pain and joint function with cartilage regeneration compared to high tibial osteotomy alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml | biological : Autologous Adipose Tissue derived MSCs 1x10\^8cells/3ml drug: saline solution |
Timeline
- Start date
- 2016-11-02
- Primary completion
- 2020-05-22
- Completion
- 2020-05-22
- First posted
- 2016-12-22
- Last updated
- 2021-01-29
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03000712. Inclusion in this directory is not an endorsement.