Phase I Clinical Trial of UC-MSCs in the Treatment of Knee Osteoarthritis
NCT Number: NCT06463847
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Knee Osteoarthritis
Interventions: DRUG: UC-MSCs
Sponsor: Wuhan Union Hospital, China
Collaborators: Wuhan Hamilton Biotechnology Co., Ltd|Guangzhou Hamilton Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 18
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-30
Completion Date: 2026-10-30
Locations: Wuhan Union Hospital, Wuhan, Hubei, 430000, China

Summary:
In recent years, the incidence rate and disability rate of osteoarthritis have continued to grow, and it has become a common chronic disease of elderly patients, second only to the "three highs", and poses a continuous threat to China's medical and health system and public health system. Knee osteoarthritis is the main type of osteoarthritis, ranking 11th in global disability diseases and 38th in disability adjusted life year loss, causing significant economic burden to patients, families, and society. At present, most of the treatment methods for KOA have limited efficacy, only relieving pain symptoms and cannot prevent cartilage damage and other tissue damage in the joints. Due to the limitations of adverse events, there is still no optimal treatment plan for KOA. Most studies believe that autologous mesenchymal stem cell transplantation is a new treatment method with good efficacy and good repair effect for mild to moderate cartilage defects. Given that there is currently no optimal treatment plan for KOA, human umbilical cord mesenchymal stem cell injection has potential development value and is of great significance for the treatment of KOA patients.

Primary Outcome Measures: Adverse Events, Incidence and severity of adverse events after administration (CTCAE 5.0), From Baseline (0 W) to 4 weeks after treatment
Secondary Outcome Measures: WOMAC (Western Ontario and McMaster Universities Arthritis Index，with the minimum value 0, and the maximum value 240, and higher scores mean a worse outcome), Changes in WOMAC score from baseline, From Baseline (0 W) to 24 hours, 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment|VAS (Visual Analogue Scale,with the minimum value 0, and the maximum value 10, and higher scores mean a worse outcome), Changes in VAS score from baseline, From Baseline (0 W) to 24 hours, 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment|Changes in knee joint range of motion from baseline, Changes in knee joint range of motion from baseline, From Baseline (0 W) to 4 weeks, 12 weeks, 24 weeks, 48 weeks after treatment]|Changes in X-Kellgren-Lawrence grading and minimum joint space width (mJSW) from baseline, Changes in X-Kellgren-Lawrence grading and minimum joint space width (mJSW) from baseline, From Baseline (0 W) to 24 weeks, 48 weeks after treatment|Changes of MRI-Roberts cartilage repair score, cartilage thickness and synovial inflammation score (reference MOAKS) compared with baseline, MRI-Roberts score includes cartilage repair score, cartilage thickness and synovial inflammation score，with different grades according to the situation，and the higher grades mean a worse situation (reference MOAKS（Magnetic Resonance imaging Osteoarthritis Knee Score），but not all indicators of MOAKS are included), From Baseline (0 W) to 24 weeks, 48 weeks after treatment