Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641860
• Other study ID #: CBMG-Allo-KOA-1.1
• Status: Completed
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: March 2018

Study information

• Verified date: September 2018
• Source: Cellular Biomedicine Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

Description:

A Phase I, Randomized, Single-centered, Double-blinded Clinical Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis.

This is a randomized,single-blind, double-blinded,phase I clinical trial. Subjects who are with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly distributed 1:1:1 to different dosage group after signing the ICF and screening tests.The treatment will accept Allogenic ReJoinTM at the first and fourth week.The duration of the therapy is 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Object has an allergic history or is of an allergic constitution.

• Subjects who understand and sign the consent form for this study.

• Age: 18-70, males and females.

• Clinical diagnosis of degenerative arthritis by Radiographic Criteria of KellgrenLawrence:Duration of pain over Grade 4(11-point numeric scale)> 4 months.

• Course of Knee osteoarthritis:6 months to 10 years;

• The VAS score :3-8 points.(the data acquisition time is to stop using all analgesic at least 3 days ).

Exclusion Criteria:

• The subject has an allergic history of medicine or food?.

• The subject'BMI is over 30.

• The subject has uncontrolled or hard-to-control diseases of cardiovascular, liver, kidney or lung, endocrine system.

• The subject has an history malignant tumour.

• The subject has complications or diseases of: systemic or rheumatoid arthritis, 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 in the 3 months prior to this trial.

• 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 has coagulation disorders.

• The subject has received arthroscopic surgery or intra-articular operations in the 6 months prior to this trial.

• The subject has received other intra-articular injections for KOA in the 6 months preceding the trial.

• The subject has received aminoglucose or chondroitin sulfate in the 6 months preceding the trial.

• The subject has plan of knee prosthesis within the trial.

• 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

• Page 4 of 4 [DRAFT] - surgery?artificial limb or joint?audiphone?artificial cochlea?middle ear shift plant?metallic intraocular foreign body etc; claustrophobia?pregnancy within 3 months?critically ill patients.

• The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases.

• The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial.

• The subject has participated in any other clinical trial in the 3 months prior to this trial.

• The subject is pregnant, lactating or planning to conceive within the next 6 months.

• The subject has any other unsuitable or adverse condition to be determined by the investigator.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Mesenchymal progenitor cells
Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use

Locations

Country	Name	City	State
China	Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Cellular Biomedicine Group Ltd.	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, recording of Adverse Events and Serious Adverse Events		12 weeks,48 weeks
Primary	WOMAC Score		48 weeks
Secondary	VAS Score		48 weeks
Secondary	SF-36		48 Weeks
Secondary	The volume of articular cartilage		48 weeks
Secondary	WORMS Score		48 weeks