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

NCT04208646 | Completed Phase 2 DMC

• 1 other identifier: CBM-ALAM.1-01
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• WOMAC Score

  The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points；96 points mean a worse outcome,will be tested at 24 weeks after the first injection

  24 weeks

Secondary Outcomes (6)

• MRI quantitative analysis of articular cartilage

  24 weeks,48 weeks

• WOMAC Score

  4、8、12、36、48 weeks

• VAS Score

  4、8、12、24、36、48 weeks

• SF-36

  4、8、12、24、36、48 weeks

• Adverse Events and Serious Adverse Events

  0d、1、3、4、8、12、24、25、27、28、36、48 weeks

Other Outcomes (1)

• Metabolic index detection

  0、4、8、12、24、36、48 weeks

Study Arms (3)

Mesenchymal progenitor cells Dosage 1

EXPERIMENTAL

Mesenchymal progenitor cells low-dose group

Biological: Mesenchymal progenitor cells

Mesenchymal progenitor cells Dosage 2

EXPERIMENTAL

Mesenchymal progenitor cells high-dose group

Biological: Mesenchymal progenitor cells

No mesenchymal progenitor cells

PLACEBO COMPARATOR

No mesenchymal progenitor cells

Biological: No mesenchymal progenitor cells

Interventions

Mesenchymal progenitor cells BIOLOGICAL

Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use

Mesenchymal progenitor cells Dosage 1; Mesenchymal progenitor cells Dosage 2

No mesenchymal progenitor cells BIOLOGICAL

No mesenchymal progenitor cells for intra- articular use

No mesenchymal progenitor cells

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；
• Age: 40-75, males and females；
• The course of knee osteoarthritis was more than 6 months and less than 10 years;
• The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the WOMAC score at least 48 hours after discontinuation of all painkillers);
• 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 has a BMI of over 30.
• 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 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

• Shanghai AbelZeta Ltd.: lead
• RenJi Hospital: collaborator
• Shanghai 6th People's Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• China-Japan Friendship Hospital: collaborator
• Huashan Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator

Study Sites (7)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, 310009, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, 200040, China

Location

Shanghai General Hospital

Shanghai, 200080, China

Location

Shanghai Jiaotong University School of Medicine, Renji Hospital

Shanghai, 200127, China

Location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Chunde Bao

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

• Changqing Zhang

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

• Guochun Wang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Chengqing Yi

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Shigui Yan

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Weiguo Wan

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Jinwu Wang

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 23, 2019
• Study Start: May 16, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-05

Locations

CN (7)