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| Name | Class |
|---|---|
| GeneWorld Co., Ltd., Ho Chi Minh | UNKNOWN |
| Van Hanh General Hospital | OTHER |
| 115 People's Hospital | OTHER_GOV |
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Adipose stem cells and platelet rich plasma can regenerate the injured cartilage.
The proposed study is two centers, unblinded, non randomized, phase I/II trial in which the patients will be treated with a single dose of autologous stromal vascular cells (SVF) in combination with platelet rich plasma (PRP).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous adipose tissue stromal vascular fraction and platelet rich plasma | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the baseline pain score (VAS) at 6 months | 6 months, 12 months, 18 months | |
| Change from baseline Lysholm score at 6 months | 6 months, 12 months, 18 months | |
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Inclusion Criteria:
Ability and willingness to undergo liposuction
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phuc V Pham, PhD | Laboratory of Stem Cell Research and Application, University of Science, VNU-HCM, VN | Study Director |
| Phuong TB Le, MSc, MD | Van Hanh Hospital, Ho Chi Minh city, VN | Principal Investigator |
| Phu D Nguyen, PhD, MD | 115 Hospital, HCM | Principal Investigator |
| Ho H La, MD | Van Hanh Hospital, Ho Chi Minh city, VN | Principal Investigator |
| Tung DX Tran, MSc, MD | Van Hanh Hospital, Ho Chi Minh city, VN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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 |
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| Change from baseline MRI assessment |
| 12 months |
| Ho Chi Minh City |
| Vietnam |
| Van Hanh Hospital, Ho Chi Minh city, VN | Ho Chi Minh City | Vietnam |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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