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

NCT02641860 | Completed Phase 1 DMC

• 1 other identifier: CBMG-Allo-KOA-1.1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Safety, recording of Adverse Events and Serious Adverse Events

  12 weeks,48 weeks

• WOMAC Score

  48 weeks

Secondary Outcomes (4)

• VAS Score

  48 weeks

• SF-36

  48 Weeks

• The volume of articular cartilage

  48 weeks

• WORMS Score

  48 weeks

Study Arms (3)

Mesenchymal progenitor cells Dosage 1

OTHER

Mesenchymal progenitor cells low-dose group

Biological: Mesenchymal progenitor cells

Mesenchymal progenitor cells Dosage 2

OTHER

Mesenchymal progenitor cells mid-dose group

Biological: Mesenchymal progenitor cells

Mesenchymal progenitor cells Dosage 3

OTHER

Mesenchymal progenitor cells high-dose group

Biological: Mesenchymal progenitor cells

Interventions

Mesenchymal progenitor cells BIOLOGICAL

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

Mesenchymal progenitor cells Dosage 1; Mesenchymal progenitor cells Dosage 2; Mesenchymal progenitor cells Dosage 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• RenJi Hospital: collaborator

Study Sites (1)

Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

• Zhao X, Ruan J, Tang H, Li J, Shi Y, Li M, Li S, Xu C, Lu Q, Dai C. Multi-compositional MRI evaluation of repair cartilage in knee osteoarthritis with treatment of allogeneic human adipose-derived mesenchymal progenitor cells. Stem Cell Res Ther. 2019 Oct 21;10(1):308. doi: 10.1186/s13287-019-1406-7.

  PMID: 31639063 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 21, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 13, 2018

Record last verified: 2018-09

Locations

CN (1)