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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Mesenchymal stem cells low-dose group
Mesenchymal stem cells mid-dose group
Mesenchymal stem cells high-dose group
Sponsored by
Cellular Biomedicine Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

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

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mesenchymal stem cells low-dose group

Mesenchymal stem cells mid-dose group

Mesenchymal stem cells high-dose group

Arm Description

Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.

Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.

Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.

Outcomes

Primary Outcome Measures

Recording of Adverse Events and Serious Adverse Events
Electrocardiogram
Vital signs
Physical examination
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)
Laboratory tests
Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests

Secondary Outcome Measures

SF-36
NRS-11
The volume of articular cartilage

Full Information

First Posted
March 11, 2013
Last Updated
April 1, 2016
Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01809769
Brief Title
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.
Collaborators
RenJi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

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 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cells low-dose group
Arm Type
Experimental
Arm Description
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.
Arm Title
Mesenchymal stem cells mid-dose group
Arm Type
Experimental
Arm Description
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
Arm Title
Mesenchymal stem cells high-dose group
Arm Type
Experimental
Arm Description
Biological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells low-dose group
Other Intervention Name(s)
Adipose tissue derived mesenchymal stem cells
Intervention Description
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells mid-dose group
Other Intervention Name(s)
Adipose tissue derived mesenchymal stem cells
Intervention Description
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stem cells high-dose group
Other Intervention Name(s)
Adipose tissue derived mesenchymal stem cells
Intervention Description
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Primary Outcome Measure Information:
Title
Recording of Adverse Events and Serious Adverse Events
Time Frame
12 weeks
Title
Electrocardiogram
Time Frame
9 weeks
Title
Vital signs
Time Frame
9 weeks
Title
Physical examination
Time Frame
9 weeks
Title
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame
24 months
Title
Laboratory tests
Description
Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
SF-36
Time Frame
24 months
Title
NRS-11
Time Frame
24 months
Title
The volume of articular cartilage
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunde Bao, M.D. & Ph.D.
Organizational Affiliation
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29417902
Citation
Song Y, Du H, Dai C, Zhang L, Li S, Hunter DJ, Lu L, Bao C. Human adipose-derived mesenchymal stem cells for osteoarthritis: a pilot study with long-term follow-up and repeated injections. Regen Med. 2018 Apr;13(3):295-307. doi: 10.2217/rme-2017-0152. Epub 2018 Feb 8.
Results Reference
derived

Learn more about this trial

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

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