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

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ClinicalTrials.gov Identifier: NCT02162693
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
RenJi Hospital
General Hospital of Chinese Armed Police Force
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Mesenchymal progenitor cells Biological: Sodium Hyaluronate Phase 2

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  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A PhaseⅡb, Randomized, Double-blinded, Clinical Trial of Autologous Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy for Knee Osteoarthritis
Study Start Date : November 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

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



Primary Outcome Measures :
  1. WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Recording of Adverse Events and Serious Adverse Events [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162693


Locations
China
General Hospital of Chinese Armed Police Force
Beijing, China
Shanghai Renji Hospital
Shanghai, China, 200127
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
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

Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT02162693     History of Changes
Other Study ID Numbers: CBMG-KOA-Ⅱb
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents