Autologous Adipose Stem Cells and Platelet Rich Plasma Therapy for Patients With Knee Osteoarthritis
NCT ID: NCT02142842
Last Updated: 2016-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2013-04-30
2015-12-31
Brief Summary
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Detailed Description
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This study aimes to evaluate the clinical efficiency of autologous adipose tissue-derived MSC transplantation in patients with confirmed osteoarthritis at grade II and III. Adipose tissue is isolated from the belly, and used for extraction of the SVF. The SVF is mixed with activated platelet-rich plasma before injection. The clinical efficiencies are evaluated by the pain score (VAS), Lysholm score, and MRI findings. SVF is isolated from about 100 mL of adipose tissue, and PRP is prepared from 20 mL of peripheral blood. Total injection volume will be about 5-10 mL. The total number of SVF to be injected is 1.0 x 10(7) to 5 x 10(7).
Conditions
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Study Design
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PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
Autologous stromal vascular fraction (SVF) and platelet rich plasma (PRP) will be injected into joints of 16 patients with grade 2, 3 radiographic OA severity with 16 patients as control.
Autologous adipose tissue stromal vascular fraction and platelet rich plasma
Interventions
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Autologous adipose tissue stromal vascular fraction and platelet rich plasma
Eligibility Criteria
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Inclusion Criteria
* Idiopathic or secondary osteoarthritis of the knee with grade 2, 3 radiographic severity
Ability and willingness to undergo liposuction
Exclusion Criteria
* Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
* Inflammatory or postinfectious arthritis.
* More than 5 degrees of varus or valgus deformity.
* Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
* Intraarticular corticosteroid injection within the previous 3 months.
* A major neurologic deficit.
* Serious medical illness with a life expectancy of less than 1 year.
* Prior admission for substance abuse
* Body Mass Index (BMI) of 40 kg/m2 or greater
* Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
* In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
18 Years
ALL
Yes
Sponsors
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GeneWorld Co., Ltd., Ho Chi Minh
UNKNOWN
Van Hanh General Hospital
OTHER
115 People's Hospital
OTHER_GOV
University of Science Ho Chi Minh City
OTHER
Responsible Party
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Phuc Van Pham
Laboratory of Stem Cell Research and Apllication
Principal Investigators
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Phuc V Pham, PhD
Role: STUDY_DIRECTOR
Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VN
Phuong TB Le, MSc, MD
Role: PRINCIPAL_INVESTIGATOR
Van Hanh Hospital, Ho Chi Minh city, VN
Phu D Nguyen, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
115 Hospital, HCM
Ho H La, MD
Role: PRINCIPAL_INVESTIGATOR
Van Hanh Hospital, Ho Chi Minh city, VN
Tung DX Tran, MSc, MD
Role: PRINCIPAL_INVESTIGATOR
Van Hanh Hospital, Ho Chi Minh city, VN
Locations
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115 Hospital, Ho Chi Minh city
Ho Chi Minh City, , Vietnam
Laboratory of Stem Cell Research and Application, University of Science, Vietnam National University, Ho Chi Minh
Ho Chi Minh City, , Vietnam
Van Hanh Hospital, Ho Chi Minh city, VN
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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1438/QDBYT
Identifier Type: -
Identifier Source: org_study_id
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