Actively Recruiting

Phase 3
Age: 40Years - 75Years
All Genders
NCT06570291

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

Led by Wuxi Cellular Biopharmaceutical Group Ltd. · Updated on 2025-07-16

520

Participants Needed

2

Research Sites

196 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understands and voluntarily signs the consent form before participating
  • Diagnosed with knee osteoarthritis based on American Rheumatology Association clinical and radiology criteria
  • Has had knee osteoarthritis for more than 6 months
  • Aged between 40 and 75 years, male or female
  • WOMAC score between 24 and 72
  • Kellgren Lawrence grade II or III on knee X-ray
  • Generally in good health and able to walk independently without wheelchairs, walking aids, or crutches
Not Eligible

You will not qualify if you...

  • Allergy to main cell preparation components such as B vitamins or amino acids
  • Previous treatment with autologous or allogeneic mesenchymal progenitor cells
  • Considered obese
  • Abnormal laboratory values including low neutrophil or platelet counts, low serum albumin, high serum creatinine, or elevated liver enzymes
  • Conditions that may affect pain or WOMAC scores
  • Serious uncontrolled diseases affecting nervous, cardiovascular, liver, kidney, gastrointestinal, or endocrine systems
  • History of malignant tumors
  • Presence of connective tissue diseases, rheumatoid arthritis, or other specified joint diseases
  • Severe infections or local knee infections within 3 months
  • Diseases of lower limbs that may interfere with knee evaluation
  • Coagulation disorders that pose safety risks or affect evaluation
  • Knee surgery within 6 months prior to the trial
  • Other intra-articular injections for knee osteoarthritis within 3 months
  • Use of aminoglucose or chondroitin sulfate within 1 month before treatment
  • Use of steroids orally or intravenously within 1 month before treatment
  • Vaccination with attenuated or live vaccines within 1 month before treatment
  • Planned or previous knee prosthesis during the trial
  • Contraindications to MRI including implanted devices or severe claustrophobia
  • Positive tests for HIV, HBV, HCV, or treponema pallidum
  • History of alcoholism, drug abuse, or mental illness in past 3 years
  • Participation in other clinical trials within 3 months
  • Fertility plans, pregnancy, lactation, or positive pregnancy test
  • Legal disability under applicable law
  • Other conditions reducing follow-up compliance as determined by investigators
  • Kellgren Lawrence grade IV on any knee joint X-ray

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

RenJi Hospital

Shanghai, China, China

Actively Recruiting

2

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

Shanghai, China

Not Yet Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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