Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

NCT06570291 | Recruiting Phase 3

• 1 other identifier: CBM-MSC-007
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Therapy

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• WOMAC score

  The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 48 weeks after the first injection

  48 weeks

• MRI quantitative analysis of articular cartilage

  24 weeks

Secondary Outcomes (9)

• WOMAC Score

  4、12、24、36、60、72、84 and 104 weeks

• MRI quantitative analysis of articular cartilage （volume change percentage）

  12、48、104 weeks

• MRI quantitative analysis of articular cartilage (volume change)

  12、24、 48 and 104 weeks

• VAS Score

  4、12、24、36、48、60、72、84、104 weeks

• SF-36

  4、12、24、36、48、60、72、84、104 weeks

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

Drug: Mesenchymal Stem Cells

Sodium hyaluronate

PLACEBO COMPARATOR

Drug: Sodium Hyaluronate Injection

Interventions

Mesenchymal Stem Cells DRUG

Allogenic adipose tissue-derived mesenchymal stem cells administrated for intra- articular use

Mesenchymal stem cells

Sodium Hyaluronate Injection DRUG

Sodium Hyaluronate administrated for intra-articular use

Sodium hyaluronate

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who understand and voluntarily sign the consent form before this study；
• According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed；Course of knee osteoarthritis was more than 6 months;
• Age: 40-75, males and females；
• The subjects' WOMAC score was 24-72
• The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III;
• Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches.

You may not qualify if:

• The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on).
• The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells.
• The subject considered obese.
• Laboratory test (any item meets): neutrophil absolute number \< 1.0 × 10\^9 / L, platelet count \< 50 × 10\^9 / L, serum albumin \< 30g / L, serum creatinine \> upper limit of 1.2 times normal value range, total bilirubin、alanine aminotransferase、aspartate aminotransferase \> upper limit of 2 times of normal value range.
• The subject has diseases or symptoms may affect VAS, WOMAC and so on.
• The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and endocrine diseases, which may prevent the subjects from participating in the study according to the judgment of the researchers.
• The subject has an history malignant tumour.
• The subject has connective tissue disease or rheumatoid arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or synovial chondromatosis.
• The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial.
• According to the researchers, the subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on.
• The subject had any other coagulation dysfunction caused by acute or chronic diseases, according to the judgment of the researchers, this coagulation dysfunction may endanger the safety of patients and / or affect the judgment of knee joint evaluation indicators.
• The subject has received arthroscopic surgery or other open surgery related to knee joint operation in the 6 months prior to this trial.
• The subject has received other intra-articular injections, including but not limited to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic glucose and so on for KOA in the 3 months preceding the trial.
• The subject has received aminoglucose or chondroitin sulfate within 1 month before the treatment.
• The subject has used dexamethasone, prednisone, hydrocortisone and other hormones orally / intravenously within 1 month before the treatment.

Sponsors & Collaborators

• Wuxi Cellular Biopharmaceutical Group Ltd.: lead

Study Sites (2)

RenJi Hospital

Shanghai, China, China

RECRUITING

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: February 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)