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| Name | Class |
|---|---|
| RAINBOW Inc. | UNKNOWN |
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The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are:
Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention?
Participants will receive the below interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell transplantation | Experimental | Intracerbral transplantation of autologous mescenchymal stem cells (HUNS001-01, 4 x 10^7 MSC cells) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stem cell Transplantation | Drug | Manufactured autologous mescenchymal stem cell (HUNS001-01) in our cell processing center will be injected into the brain, totally 4 x 10^7 cells, in 2 brain sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of HUNS001-01 administration | The frequency of the improvement in mRS of disability by 1 or more from baseline | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of HUNS001-01 administration | frequency of Adverse Event | one year |
| Change in NIHSS examination | Mean improvement of NIHSS (0-42, higher score means worse outcome) |
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Inclusion criteria
Exclusion criteria
14. Any condition that in the judgement of the investigator would place the patient at undue risk
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kota Kurisu, M.D., Ph.D. | Contact | +81-11-706-1161 | 5987 | kkurisu0912@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido University Hospital | Recruiting | Sapporo | Hokkaido | 0608638 | Japan |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| one year |
| Change in FIM examination | Mean improvement of FIM (18-126, higher score means better outcome) | one year |
| Change in Fugl-Myer examination | Mean improvement of Fugl-Myer (0-226, higher score means better outcome) | one year |
| Change in Barthal index examination | Mean improvement of Barthal index (0-100, higher score means better outcome) | one year |
| Change in FDG-PET examination | Mean improvement of FDG-PET set for ipsilateral motor cortex | one year |
| Change in IMZ-SPECT examination | Mean improvement of IMZ-SPECT set for ipsilateral motor cortex | one year |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D014180 |
| Transplantation |
| D013514 | Surgical Procedures, Operative |