Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04208646
Other study ID # CBM-ALAM.1-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date May 16, 2020
Est. completion date July 31, 2023

Study information

Verified date May 2023
Source Cellular Biomedicine Group Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date July 31, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Mesenchymal progenitor cells
Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use
No mesenchymal progenitor cells
No mesenchymal progenitor cells for intra- articular use

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing
China The Second Affiliated hospital of Zhejiang University School of Medicine Hangzhou
China Huashan Hospital Affiliated to Fudan University Shanghai
China Shanghai General Hospital Shanghai
China Shanghai Jiaotong University School of Medicine, Renji Hospital Shanghai
China Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine Shanghai
China Shanghai Sixth People's Hospital Shanghai

Sponsors (8)

Lead Sponsor Collaborator
Cellular Biomedicine Group Ltd. China-Japan Friendship Hospital, Huashan Hospital, RenJi Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai 6th People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 0?4?8?12?24?36?48 weeks
Primary 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 MRI quantitative analysis of articular cartilage Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24?48 weeks after the first injection 24 weeks,48 weeks
Secondary 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 4?8?12?36?48 weeks
Secondary 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 4?8?12?24?36?48 weeks
Secondary 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 4?8?12?24?36?48 weeks
Secondary 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 0d?1?3?4?8?12?24?25?27?28?36?48 weeks
Secondary 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 0d?1?3?4?8?12?24?25?27?28?36?48 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04651673 - Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Completed NCT05677399 - Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise. N/A
Active, not recruiting NCT04043819 - Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis Phase 1
Recruiting NCT06000410 - A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee Phase 3
Completed NCT05014542 - Needling Techniques for Knee Osteoarthritis N/A
Recruiting NCT05892133 - Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty N/A
Recruiting NCT05528965 - Parallel Versus Perpendicular Technique for Genicular Radiofrequency N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Active, not recruiting NCT02003976 - A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone N/A
Active, not recruiting NCT04017533 - Stability of Uncemented Medially Stabilized TKA N/A
Completed NCT04779164 - The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis N/A
Recruiting NCT04006314 - Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis N/A
Recruiting NCT05423587 - Genicular Artery Embolisation for Knee Osteoarthritis II N/A
Enrolling by invitation NCT04145401 - Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
Active, not recruiting NCT03781843 - Effects of Genicular Nerve Block in Knee Osteoarthritis N/A
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05324163 - Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis Phase 3
Completed NCT05529914 - Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis N/A
Recruiting NCT05693493 - Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA? N/A
Not yet recruiting NCT05510648 - Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis N/A