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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Mesenchymal progenitor cells

Sodium Hyaluronate

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The subject is between 18-70 years of age, regardless of gender
The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4
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:

The subject has an allergic history or is of an allergic constitution
The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung
The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system
The subject has severe infectious diseases or a malignant tumour
The subject has coagulation disorders
The subject has a BMI of over 30
The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial
The subject has received other intra-articular injections in the 2 months preceding the trial
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
The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases
The subject has a history of alcoholism, drug abuse, or mental illness
The subject has participated in any other clinical trial in the 3 months prior to this trial
The subject is pregnant, lactating or is planning to conceive within the next 6 months
The subject has any other unsuitable or adverse condition to be determined by the investigator

Sites / Locations

General Hospital of Chinese Armed Police Force
Shanghai Renji Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesenchymal progenitor cells

Sodium Hyaluronate

Arm Description

Administrated for intra-articular use of Mesenchymal progenitor cells

Administrated for intra-articular use of Sodium Hyaluronate.

Outcomes

Primary Outcome Measures

WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)

Secondary Outcome Measures

Recording of Adverse Events and Serious Adverse Events

Full Information

NCT ID

NCT02162693

First Posted

March 19, 2014

Last Updated

November 14, 2017

Sponsor

Cellular Biomedicine Group Ltd.

Collaborators

RenJi Hospital, General Hospital of Chinese Armed Police Force

1. Study Identification

Unique Protocol Identification Number

NCT02162693

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cellular Biomedicine Group Ltd.

Collaborators

RenJi Hospital, General Hospital of Chinese Armed Police Force

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mesenchymal progenitor cells

Arm Type

Experimental

Arm Description

Administrated for intra-articular use of Mesenchymal progenitor cells

Arm Title

Sodium Hyaluronate

Arm Type

Active Comparator

Arm Description

Administrated for intra-articular use of Sodium Hyaluronate.

Intervention Type

Biological

Intervention Name(s)

Mesenchymal progenitor cells

Intervention Description

Administrated for intra-articular injection

Intervention Type

Biological

Intervention Name(s)

Sodium Hyaluronate

Primary Outcome Measure Information:

Title

WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Recording of Adverse Events and Serious Adverse Events

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The subject is between 18-70 years of age, regardless of gender The subject has a Kellgren-Lawrence grading, as determined by American College of Rheumatology (ACR) criteria for osteoarthritis of the knee, below grade 4 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: The subject has an allergic history or is of an allergic constitution The subject has uncontrolled or hard-to-control diseases of heart, liver, kidney or lung The subject has uncontrolled or hard-to-control diseases of cardiovascular or endocrine system The subject has severe infectious diseases or a malignant tumour The subject has coagulation disorders The subject has a BMI of over 30 The subject has used traditional Chinese medicine containing anti-inflammatory agents in the 2 weeks preceding the trial The subject has received other intra-articular injections in the 2 months preceding the trial 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 The subject tests positive for: HIV, hepatitis virus, syphilis or other infectious diseases The subject has a history of alcoholism, drug abuse, or mental illness The subject has participated in any other clinical trial in the 3 months prior to this trial The subject is pregnant, lactating or is planning to conceive within the next 6 months The subject has any other unsuitable or adverse condition to be determined by the investigator

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunde Bao, MD

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhongwen Zhang, MD

Organizational Affiliation

General Hospital of Chinese Armed Police Force

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Hospital of Chinese Armed Police Force

City

Beijing

Country

China

Facility Name

Shanghai Renji Hospital

City

Shanghai

ZIP/Postal Code

200127

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

31113476

Citation

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.

Results Reference

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

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