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| Name | Class |
|---|---|
| Far Eastern Memorial Hospital | OTHER |
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Osteoarthritis (OA) is a common and incurable disease for the elderly in Taiwan, so it is an important mission to develop a new treatment for OA. Recently, cellular therapy is a new and popular medical treatment around the world, one of them is "Mesenchymal Stromal Cells (MSCs)". MSCs are found in many tissues of human body and play an important role for repairing, regeneration, anti-inflammatory and chondrogenesis. So, MSC product, RegStem, for osteoarthritis treatment becomes a developing target for new generation drugs.
This study is to isolate and expand MSCs(RegStem) from infrapatellar fat pad of subject. When the number of MSCs expands to 1×10^8, cell will be cryopreserved in the liquid nitrogen tank until all release tests passed. On the distribution day, cell will be thawed and injected into joint cavity of patient (5×10^7). Subjects will be monitored after MSC product infusion of seven days, one month, six months and one year. The monitoring items include the changes of knee (by appearance, X-ray and MRI of knee) and pain improvement (by questionnaire).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RegStem | Experimental | Autologous MSC, 5×10^7 cells, one injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RegStem | Biological | RegStem, 1.5 ml, one injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of RegStem by incidence of adverse events and changes in physical examinations, vital signs and the results of clinical lab tests. | 48 weeks | |
| Clinical assessment of International Knee Documentation Committee (IKDC) score | Assess symptoms of knee, sport activity and function of knee | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment of Knee injury and Osteoarthritis Outcome Score (KOOS) | 48 weeks | |
| Clinical assessment of visual analogue scale (VAS) | 48 weeks | |
| Clinical assessment of knee X-ray |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | Taipei | Taiwan |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 14, 2022 | |
| Reset | Jul 12, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2022 | Jul 12, 2023 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| 48 weeks |
| Clinical assessment of knee MRI | 48 weeks |
| D012216 |
| Rheumatic Diseases |