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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208646
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
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
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Mesenchymal progenitor cells Biological: No mesenchymal progenitor cells Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Controlled Phase II Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) for the Treatment of Knee Osteoarthritis
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Mesenchymal progenitor cells Dosage 1
Mesenchymal progenitor cells low-dose group
Biological: Mesenchymal progenitor cells
Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use

Experimental: Mesenchymal progenitor cells Dosage 2
Mesenchymal progenitor cells high-dose group
Biological: Mesenchymal progenitor cells
Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use

Placebo Comparator: No mesenchymal progenitor cells
No mesenchymal progenitor cells
Biological: No mesenchymal progenitor cells
No mesenchymal progenitor cells for intra- articular use




Primary Outcome Measures :
  1. WOMAC Score [ Time Frame: 24 weeks ]
    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


Secondary Outcome Measures :
  1. MRI quantitative analysis of articular cartilage [ Time Frame: 24 weeks,48 weeks ]
    Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24、48 weeks after the first injection

  2. WOMAC Score [ Time Frame: 4、8、12、36、48 weeks ]
    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

  3. VAS Score [ Time Frame: 4、8、12、24、36、48 weeks ]
    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

  4. SF-36 [ Time Frame: 4、8、12、24、36、48 weeks ]
    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

  5. Adverse Events and Serious Adverse Events [ Time Frame: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks ]
    AE and SAE, will be assessed at 0d、1、3、4、8、12、24、25、27、28、36、48 weeks

  6. Changes of laboratory test indexes and vital signs [ Time Frame: 0d、1、3、4、8、12、24、25、27、28、36、48 weeks ]
    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


Other Outcome Measures:
  1. Metabolic index detection [ Time Frame: 0、4、8、12、24、36、48 weeks ]
    Levels of cartilage metabolism and inflammatory biomarkers in serum and urine will be tested at 0、4、8、12、24、36、48 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 diagnosis 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:

  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. 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 in the next 3 months; 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208646


Contacts
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Contact: Chunde Bao, M.D. & Ph.D. 021-587523545 xck@renji.com

Locations
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China
China-Japan Friendship Hospital
Beijing, China, 100029
Principal Investigator: Guochun Wang         
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, China, 310009
Principal Investigator: Shigui Yan         
Huashan Hospital Affiliated to Fudan University
Shanghai, China, 200040
Contact: Weiguo Wan         
Shanghai General Hospital
Shanghai, China, 200080
Principal Investigator: Chengqing Yi         
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, China, 200127
Principal Investigator: Chunde Bao, MD         
Shanghai Sixth People's Hospital
Shanghai, China, 200233
Principal Investigator: Changqing Zhang         
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
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
Investigators
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Principal Investigator: Chunde Bao Shanghai Jiaotong University School of Medicine, 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
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Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT04208646    
Other Study ID Numbers: CBM-ALAM.1-01
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases