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CompletedNCT04208646Updated Aug 1, 2023

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

A Phase 2 interventional study of Mesenchymal progenitor cells and No mesenchymal progenitor cells in Knee Osteoarthritis, sponsored by Shanghai AbelZeta Ltd.. Completed at 7 sites in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-01.

Sponsored by Shanghai AbelZeta Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

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

Read the detailed description

A Multicenter, Randomized, Double-blind, Controlled Phase II Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.

This is a multicenter, randomized, double-blinded, phase II clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different group after signing the ICF and screening tests. Each group was treated for two cycles. The patients were followed up to 48 weeks after the first treatment.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 106 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Shanghai AbelZeta Ltd. is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects who understand and voluntarily sign the consent form before this study;
  2. According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed;
  3. Age: 40-75, males and females;
  4. The course of knee osteoarthritis was more than 6 months and less than 10 years;
  5. 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);
  6. The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III;
  7. Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches.

Exclusion criteria

Exclusion Criteria:

  1. The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on).
  2. The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells.
  3. The subject has a BMI of over 30.
  4. 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.
  5. The subject has diseases or symptoms may affect VAS, WOMAC and so on.
  6. 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.
  7. The subject has an history malignant tumour.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. The subject has received arthroscopic surgery or other open surgery related to knee joint operation in the 6 months prior to this trial.
  13. 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.
  14. The subject has received aminoglucose or chondroitin sulfate within 1 month before the treatment.
  15. The subject has used dexamethasone, prednisone, hydrocortisone and other hormones orally / intravenously within 1 month before the treatment.
  16. The subject has undergone knee prosthesis or a plan of knee prosthesis within the trial.
  17. The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip after aneurysm surgery, drug infusion device implanted in vivo, any electronic device implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill patient and so on.
  18. The subject tests positive for: HIV, HBV, HCV and treponema pallidum.
  19. The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.
  20. The subject has participated in any other clinical trial in the 3 months prior to this trial.
  21. The subject (including male subjects) has fertility, sperm donation or egg donation plans during the trial period; the female subject is pregnant, lactating or having a positive pregnancy test.
  22. The subject is legally disabled by reference to the law of the people's Republic of China on the protection of disabled persons (April 2008).
  23. The subject has any other unsuitable condition (such as factors reducing the follow-up compliance) to be determined by the investigator.

24.The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of the subjects was grade IV.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
106 participants (actual)

Study arms

  • Experimental
    Mesenchymal progenitor cells Dosage 1

    Mesenchymal progenitor cells low-dose group

    Biological: Mesenchymal progenitor cells

  • Experimental
    Mesenchymal progenitor cells Dosage 2

    Mesenchymal progenitor cells high-dose group

    Biological: Mesenchymal progenitor cells

  • Placebo comparator
    No mesenchymal progenitor cells

    No mesenchymal progenitor cells

    Biological: No mesenchymal progenitor cells

Interventions

  • BiologicalMesenchymal progenitor cells

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

  • BiologicalNo mesenchymal progenitor cells

    No mesenchymal progenitor cells for intra- articular use

06

What researchers measure

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

    Time frame: 24 weeks

Secondary outcomes

  1. MRI quantitative analysis of articular cartilage

    Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24、48 weeks after the first injection

    Time frame: 24 weeks,48 weeks

  2. WOMAC Score

    The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome, will be tested at 4、8、12、36、48 weeks after the first injection

    Time frame: 4、8、12、36、48 weeks

  3. VAS Score

    Visual Analogue Scale/Score;0-10 points;10 points mean a worse outcome,will be tested at 4、8、12、24、36、48 weeks after the first injection

    Time frame: 4、8、12、24、36、48 weeks

  4. SF-36

    The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points;100 points mean a better outcome, will be tested at 4、8、12、24、36、48 weeks after the first injection

    Time frame: 4、8、12、24、36、48 weeks

  5. Adverse Events and Serious Adverse Events

    AE and SAE, will be assessed at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

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

  6. Changes of laboratory test indexes and vital signs

    Vital signs, physical examination, clinical laboratory tests:infectious disease check, blood coagulation test , blood check, urine check, blood biochemical test, immunological examination, tumor screening ,will be tested at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

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

Other outcomes

  1. Metabolic index detection

    Levels of cartilage metabolism and inflammatory biomarkers in serum and urine will be tested at 0、4、8、12、24、36、48 weeks

    Time frame: 0、4、8、12、24、36、48 weeks

07

Study locations

7 sites
  • China-Japan Friendship Hospital
    Beijing, 100029, China
  • The Second Affiliated hospital of Zhejiang University School of Medicine
    Hangzhou, 310009, China
  • Huashan Hospital Affiliated to Fudan University
    Shanghai, 200040, China
  • Shanghai General Hospital
    Shanghai, 200080, China
  • Shanghai Jiaotong University School of Medicine, Renji Hospital
    Shanghai, 200127, China
  • Shanghai Sixth People's Hospital
    Shanghai, 200233, China
  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
    Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04208646
Lead sponsor
Shanghai AbelZeta Ltd.
Collaborators
RenJi Hospital, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University, China-Japan Friendship Hospital, Huashan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Responsible party
Sponsor
First posted
Dec 23, 2019
Start date
May 16, 2020
Primary completion
Jun 30, 2021
Completion
Jul 31, 2023
Last update
Aug 1, 2023

Study contacts

Chunde Bao
principal investigator · Shanghai Jiaotong University School of Medicine,Renji Hospital
Changqing Zhang
principal investigator · Shanghai 6th People's Hospital
Guochun Wang
principal investigator · China-Japan Friendship Hospital
Chengqing Yi
principal investigator · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shigui Yan
principal investigator · Second Affiliated Hospital, School of Medicine, Zhejiang University
Weiguo Wan
principal investigator · Huashan Hospital
Jinwu Wang
principal investigator · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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