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| Name | Class |
|---|---|
| A2 Healthcare Taiwan Corporation | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elixcyte 8mL | Experimental | ADSC 6.4*10^7 cells, allogeneic injection, one time injection on Day 1 |
|
| Hya Joint Plus | Active Comparator | Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc., one time injection on Day 1 |
|
| Elixcyte 4mL | Experimental | ADSC 3.2*10^7 cells, allogeneic injection, one time injection on Day 1 |
|
| Elixcyte 2mL | Experimental | ADSC 1.6*10^7 cells, allogeneic injection, one time injection on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elixcyte 8 ml | Biological | ADSC 6.4*10^7 cells, allogeneic injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment | Weeks 0, 24 | |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels | Weeks 0, 2, 4, 12, 24, 36, 48 | |
| Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Han Chang, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Cheng-Fong Chen, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112 | Taiwan | |||
| Chang Gung Memorial Hospital Linkou |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34717765 | Derived | Chen CF, Hu CC, Wu CT, Wu HH, Chang CS, Hung YP, Tsai CC, Chang Y. Treatment of knee osteoarthritis with intra-articular injection of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE(R): a phase I/II, randomized, active-control, single-blind, multiple-center clinical trial. Stem Cell Res Ther. 2021 Oct 30;12(1):562. doi: 10.1186/s13287-021-02631-z. |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Hya Joint Plus |
| Device |
Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc. |
|
| Elixcyte 4 ml | Biological | ADSC 3.2*10^7 cells, allogeneic injection |
|
| Elixcyte 2 ml | Biological | ADSC 1.6*10^7 cells, allogeneic injection |
|
| Weeks 0, 2, 4, 12, 24, 36, 48 |
| Changes from baseline to post-treatment visits of MRI examination results | Weeks 0, 24, 48, 72, 96 |
| Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC | Weeks 0, 2, 4, 12, 36, 48 |
| Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96 | Week 0, 2, 4, 12, 24, 48, 96 |
| Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96 | Weeks 0, 2, 4, 12, 24 |
| Time to subject first time consumes acetaminophen | Weeks 0, 2, 4, 12, 24 |
| Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID) | Weeks 0, 2, 4, 12, 24 |
| Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment | Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96 |
| Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment | Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96 |
| Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation. | Weeks 0, 24, 48, 72, 96 |
| Taoyuan City |
| 333 |
| Taiwan |
| D012216 |
| Rheumatic Diseases |