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Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01809769
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : April 4, 2016
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
Cellular Biomedicine Group Ltd.

Study Description
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Brief Summary:
Two injections in total and 3 ml autologous adipose-tissue-derived stem cells(haMSCs) for each injection; time-points for intervention: 1) initial injection; 2) 3 weeks following initial injection.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Mesenchymal stem cells low-dose group Biological: Mesenchymal stem cells mid-dose group Biological: Mesenchymal stem cells high-dose group Phase 1 Phase 2

Detailed Description:
Adipose (fat) tissue is removed by lipo-aspiration (this may take up to 40 minutes). The fat is processed on-site to isolate and obtain the MSCs,then proliferate them. The suspension of the cells is injected into the knee joint under ultrasound guidance. (about 20 minutes).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis by Intra-articular Injection: A PhaseⅠ/Ⅱa, Randomized and Double-blinded Clinical Trial
Study Start Date : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal stem cells low-dose group
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.
 Biological: Mesenchymal stem cells low-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Other Name: Adipose tissue derived mesenchymal stem cells
Experimental: Mesenchymal stem cells mid-dose group
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
 Biological: Mesenchymal stem cells mid-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Other Name: Adipose tissue derived mesenchymal stem cells
Experimental: Mesenchymal stem cells high-dose group
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
 Biological: Mesenchymal stem cells high-dose group
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Other Name: Adipose tissue derived mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Recording of Adverse Events and Serious Adverse Events [ Time Frame: 12 weeks ]
  2. Electrocardiogram [ Time Frame: 9 weeks ]
  3. Vital signs [ Time Frame: 9 weeks ]
  4. Physical examination [ Time Frame: 9 weeks ]
  5. WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index) [ Time Frame: 24 months ]
  6. Laboratory tests [ Time Frame: 9 weeks ]
    Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: 24 months ]
  2. NRS-11 [ Time Frame: 24 months ]
  3. The volume of articular cartilage [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who understand and sign the consent form for this study.
  • Age: 40-70, males and females.
  • Clinical diagnosis of degenerative arthritis by Radiographic Criteria of Kellgren and Lawrence.
  • Patients who can't treat with traditional medication and need a arthroplasty.
  • Duration of pain over Grade 4(11-point numeric scale)> 4 months.

Exclusion Criteria:

  • Women who are pregnant or breast feeding or planning to become pregnant during the study.
  • Objects who administer with a anti-inflammatory drugs within 14 days prior to inclusion in the study.
  • History or current evidence of alcohol or drug abuse or is a recreational user of illicit drugs or prescription medications.
  • Treatment with intra-articular injection therapy within 2 months prior to screen.
  • Other joint diseases except degenerative arthritis : systemic or rheumatic or inflammatory chondropathy, chondrocalcinosis, hemachromatosis, inflammatory joint disease, avascular necrosis of the femoral head, Paget's disease, hemophilic arthropathy, infectional arthritis, Charcot's disease, villonodular synovitis, synovial chondromatosis.
  • Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
  • Serious pre-existing medical conditions like Cardiovascular Diseases, Renal Diseases, Liver Diseases, Endocrine Diseases, Cancer and Diabetes Mellitus.
  • Overweight expressed as body mass index (BMI) greater than 30 (obesity grade II).
  • Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Contacts and Locations
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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): NCT01809769


Locations
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China, Shanghai
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Cellular Biomedicine Group Ltd.
RenJi Hospital
Investigators
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Principal Investigator: Chunde Bao, M.D. & Ph.D. Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cellular Biomedicine Group Ltd.
ClinicalTrials.gov Identifier: NCT01809769     History of Changes
Other Study ID Numbers: CBMG-KOA-1.1
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases