Safety Study of Intra-Joint Injection of autologous adipose-derived stem cells Produced from a Very Small Amount of Subcutaneous Adipose Tissue for Knee Osteoarthritis.
- Conditions
- Osteoarthritis
- Registration Number
- JPRN-jRCTb030230603
- Lead Sponsor
- Saita Yoshitomo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 6
1.Men and women whose consent acquisition date is more than 18 years.
2.Patients who have pain at the target site more than 3 months before the date of consent.(Patients who have no positive effects of previous conservative treatment such as hyaluronic acid or PRP therapy.)
3.Patients diagnosed as osteoarthritis (KL grade 1 or more) by upright knee radiograph.
4. VAS 40 or higher (For patients with pain in both knees, the one with the higher VAS value will be targeted; if the VAS values are the same, ASCs are administered to the one knee determined by the doctor.)
5.Patients who have received sufficient explanation using ICF and understand the contents, and who have obtained written consent to participate in the study group based on their free will.
1.Patients with locolotive syndrome, malignant tumor, contagious disease, or blood disorder.
2.Patients who have had knee surgery within the last 6 months or had intra-articular knee injections within the last 3 months.
3.Patients with psychiatric disorders or substance abuse disorders, patients who have difficulty communication, or pregnant women.
4.Patients for whom doctors decide as not appropriate to participate in the clinical study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method