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This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | intravenous umbilical cord derived mesenchymal stem cells |
|
| Placebo Comparator | Placebo Comparator | intravenous placebo solution with the same appearance as the treatment group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord-derived Mesenchymal Stem Cells | Biological | umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of modified Rankin Scale (mRS) 0-2 | the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome | 90 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of modified Rankin Scale (mRS) 0-2 | the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome | 180,360 Days |
| changes in Fugl-Meyer scale | Fugl-Meyer Assessment Scale ranges from 0 to 100. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 360days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Hui-Sheng, Doctor | General Hospital of Shenyang Military Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution
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Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.
| Placebo | Drug | intravenous placebo solution with the same appearance as the treatment group. |
|
| 90days;180days;360days |
| changes in Purdue hand function test | The changes of fine motor function were evaluated by Purdue hand function test | 90days;180days;360days |
| changes in box and block test | The changes of fine motor function were evaluated by box and block test | 90days;180days;360days |
| Proportion of modified Rankin Scale (mRS) 0-1 | the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS | 90days;180days;360days |
| changes in the national institutes of health stroke scale (NIHSS) | NIHSS ranges from 0-42, and high NIHSS means bad outcome | 90days;180days;360days |
| changes in Mini-mental State Examination (MMSE) score | MMSE score ranges from 0 to 30. | 90days;180days;360days |
| changes in Montreal Cognitive Assessment (MoCA) score | MOCA score ranges from 0 to 30. | 90days;180days;360days |
| The changes of head images | head images included flair, DTI | 90days;180days;360days |
| changes in some serum biomarkers | serum biomarkers included CPEC, VEGF, BDNF, MMP-9 | 90days;180days;360days |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |