Stem Cell Treatment for Knee Osteoarthritis

Recruiting at7 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Nature Cell Co. Ltd.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment that uses cells from a patient's own fat to help repair knee damage in people with knee osteoarthritis. The cells are injected into the knee to reduce pain and improve joint function. This type of therapy has been increasingly studied and used for treating knee osteoarthritis due to its potential to reduce pain and improve joint function.

Research Team

Eligibility Criteria

This trial is for adults with knee osteoarthritis who have significant pain and limited function in one knee, but less severe symptoms in the other. They must not have used certain medications or treatments recently and should be free of serious health issues like heart disease or cancer. Participants cannot have had stem cell therapy before and must agree to avoid specific pain medications during the study.

Inclusion Criteria

Subject who has ≥ 34 on WOMAC function score at Screening and Baseline

Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)

You have osteoarthritis of the knee.

Exclusion Criteria

Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening

Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening

Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 12 months prior to Screening

Treatment Details

Interventions

• JointStem (Stem Cell Therapy)
• Placebo Control (Other)

Trial Overview The trial is testing JointStem, a treatment using patient's own fat-derived stem cells, against a placebo. About 140 participants will be randomly assigned to receive either JointStem or a placebo injection in their knees. The study aims to determine if JointStem can improve knee function and reduce pain more effectively than a placebo.

Participant Groups

Group I: JointStem Experimental Treatment 1 Intervention

Autologous Adipose tissue derived Mesenchymal Stem Cells(AdMSC)

Group II: Placebo Placebo Group 1 Intervention

Normal Saline with Autologous Serum

Who Is Running the Clinical Trial?

Nature Cell Co. Ltd.

Lead Sponsor

Trials

5

Recruited

300+