Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells (MPCs) Therapy for Knee Osteoarthritis

A PhaseⅡb, Randomized, Double-blinded, Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis

Current medication treatments for KOA aim to relieve inflammation and pain, but they do little to delay or reverse the disease progression and most medications have obvious side effects. When the conservative treatments are useless to patients and joint deformities and joint disfunction, the patients may require surgery. Although surgery of the joints can relieve the pain temporarily, long-term effect (over 10 years) is hard to achieve.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: Mesenchymal progenitor cells; Biological: Sodium Hyaluronate

Detailed Description

Human adipose-derived mesenchymal progenitor cells (haMPCs) are obtained through a series of procedures: firstly, the fresh adipose tissue is digested with collagenase, filtered, centrifuged and then discard mature adipose cells to obtain adipose tissue-derived nuclear cells also called stromal vascular fraction cells (SVFs). In the end, haMPCs are prepared after being purified andamplified to P2-P5. When induced by specific factors, haMPCs have a potential for multilineage differentiation towards bone, cartilage and fat tissue both in vivo and in vitro. The haMPCs can secrete a number of soluble mediators to stimulate the proliferation of endogenous progenitor cells, to act as nutrients, to be immunosuppressive, to be anti-inflammatory, to prevent fibrosis and promote angiogenesis. The cytokines secreted by haMPCs play a synergic role in restoring the dynamic balance of synthesis and decompositon of cartilage tissue, and finally to repair the impaired cartilage.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • General Hospital of Chinese Armed Police Force
  • Shanghai, China, 200127
    • Shanghai Renji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subject is between 18-70 years of age, regardless of gender
2. The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
3. The subject or the subject's legally acceptable representative must be willing to participate in the trial, to receive cell therapy and to provide signed and dated informed consent forms

Exclusion Criteria:

1. The subject has an allergic history or is of an allergic constitution
2. The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
3. The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
4. The subject has severe infectious diseases or a malignant tumour
5. The subject has coagulation disorders
6. The subject has a BMI of over 30
7. The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
8. The subject has received other intra-articular injections in the 2 months preceding the trial
9. The subject has complications or diseases of: systemic or rheumatoid arthritis, Chondrocalcinosis articular， Hemochromatosis，inflammatory arthropathy，avascular necrosis of femoral head，Paget's disease，hemophilic arthropathy，infectional arthritis，Charcot's disease，villonodular synovitis or synovial chondromatosis
10. The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
11. The subject has a history of alcoholism, drug abuse, or mental illness
12. The subject has participated in any other clinical trial in the 3 months prior to this trial
13. The subject is pregnant, lactating or is planning to conceive within the next 6 months
14. The subject has any other unsuitable or adverse condition to be determined by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesenchymal progenitor cells; Administrated for intra-articular use of Mesenchymal progenitor cells	Biological: Mesenchymal progenitor cells; Administrated for intra-articular injection
Active Comparator: Sodium Hyaluronate; Administrated for intra-articular use of Sodium Hyaluronate.	Biological: Sodium Hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Recording of Adverse Events and Serious Adverse Events	12 months

Collaborators and Investigators

• Sponsor: Cellular Biomedicine Group Ltd.
• Collaborators: RenJi Hospital; General Hospital of Chinese Armed Police Force
• Investigators: Principal Investigator: Chunde Bao, MD, RenJi Hospital; Principal Investigator: Zhongwen Zhang, MD, General Hospital of Chinese Armed Police Force

Publications and helpful links

General Publications

• Lu L, Dai C, Zhang Z, Du H, Li S, Ye P, Fu Q, Zhang L, Wu X, Dong Y, Song Y, Zhao D, Pang Y, Bao C. Treatment of knee osteoarthritis with intra-articular injection of autologous adipose-derived mesenchymal progenitor cells: a prospective, randomized, double-blind, active-controlled, phase IIb clinical trial. Stem Cell Res Ther. 2019 May 21;10(1):143. doi: 10.1186/s13287-019-1248-3.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 19, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 14, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CBMG-KOA-Ⅱb