Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis
ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorShanghai IxCell Biotechnology Co., LTD
About this trial
To evaluate the efficacy of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.
To evaluate the safety of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with knee osteoarthritis according to the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)" by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association;
Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional clinical treatments such as hormones, opioids, non-steroidal anti-inflammatory drugs, viscosupplementary therapy, etc.;
The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;
Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;
Disqualifiers
Patients diagnosed with secondary knee osteoarthritis;
Patients with other diseases that cause knee joint dysfunction or affect the joint (such as acute joint injuries caused by trauma, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, gouty arthritis, symptomatic chondrocalcinosis, osteonecrosis, or active infections, lower limb arteriosclerosis obliterans, etc.);
Patients with obvious varus or valgus deformities (greater than 15 degrees) in the knee joint or with obvious flexion contractures;
Patients who have previously used stem cell therapy;
Trial design
Design model
Parallel
Treatments tested in this trial
Human umbilical cord mesenchymal stem cells
Biological/Vaccinea single intra-articular injection of IxCell hUC-MSC-O at a dose of 5.0×10\^7 cells with a volume of 2.0 mL
Placebo
Biological/VaccineSodium Chloride Injection
Treatment groups
398 Participants
are divided into 2 treatment groupsGroup A: MSC groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
WOMAC total score
The change in WOMAC total score from baseline at 48 weeks post-dose.
Time frame
48 week2
cartilage damage
The change in cartilage damage area from baseline at 48 weeks post-dose.
Time frame
48 weekSponsors and contacts
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Source ClinicalTrials.gov