Autologous Adipose Tissue Derived Mesenchymal Stem Cells Therapy for Patients With Knee Osteoarthritis
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 knee-osteoarthritis
Started Mar 2013
Typical duration for phase_1 knee-osteoarthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 4, 2016
April 1, 2016
2 years
March 11, 2013
April 1, 2016
Conditions
Outcome Measures
Primary Outcomes (6)
Recording of Adverse Events and Serious Adverse Events
12 weeks
Electrocardiogram
9 weeks
Vital signs
9 weeks
Physical examination
9 weeks
WOMAC Score(The Western Ontario and McMaster Universities Osteoarthritis Index)
24 months
Laboratory tests
Routine blood and urine tests, hepatic and renal functions tests, blood lipid and glucose tests, immunologic tests
9 weeks
Secondary Outcomes (3)
SF-36
24 months
NRS-11
24 months
The volume of articular cartilage
24 months
Study Arms (3)
Mesenchymal stem cells low-dose group
EXPERIMENTALBiological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 1 x 10 E7 cells (3 ml), Frequency: 0,3 weeks.
Mesenchymal stem cells mid-dose group
EXPERIMENTALBiological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage: 2 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
Mesenchymal stem cells high-dose group
EXPERIMENTALBiological: Mesenchymal progenitor cells. Administrated for intra-articular use. Dosage:5 x 10 E7 cells (3 ml). Frequency: 0,3 weeks.
Interventions
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who are pregnant or breast feeding or planning to become pregnant during 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).
- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai AbelZeta Ltd.lead
- RenJi Hospitalcollaborator
Study Sites (1)
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
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.
PMID: 29417902DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunde Bao, M.D. & Ph.D.
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2013
First Posted
March 13, 2013
Study Start
March 1, 2013
Primary Completion
March 1, 2015
Study Completion
July 1, 2015
Last Updated
April 4, 2016
Record last verified: 2016-04