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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2043190112 | Registry Identifier | Japan Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Life Science Institute, Inc. | UNKNOWN |
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The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL2020 cells | Experimental | Intravenous injection of CL2020 cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL2020 cells | Biological | 1.5 million or 15 million cells, IV on day 5 to 14 of birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | Any adverse events are summarized. | until 12 weeks after the administration |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators) | Incidence of composite endpoints is summarized. | at 12, 26, 38, 52, and 78 weeks after administration |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshiaki Sato, MD, PhD | Department of Center for Maternal Neonatal Care, Nagoya University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Nagoya | Aich | 466-8560 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39401019 | Derived | Sato Y, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Ando M, Tsuda K, Iwata O, Muramatsu Y, Kidokoro H, Hirakawa A, Hayakawa M; SHEILD team. Safety and tolerability of a Muse cell-based product in neonatal hypoxic-ischemic encephalopathy with therapeutic hypothermia (SHIELD trial). Stem Cells Transl Med. 2024 Nov 12;13(11):1053-1066. doi: 10.1093/stcltm/szae071. | |
| 35473726 |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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3 + 3 dose escalation study design
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Mortality is summarized.
| all of the clinical trial period (up to 44 months) |
| Overall survival | Overall survival is summarized. | all of the clinical trial period (up to 44 months) |
| Duration of continuous respiratory support | Duration of continuous respiratory support is summarized. | up to 78 weeks |
| Duration of continuous use of vasopressors or pulmonary vasodilators | Duration of continuous use of vasopressors or pulmonary vasodilators is summarized. | up to 78 weeks |
| The composite score of cognitive scale, language scale, motor scale, social-emotional scale, and adaptive behavior scale in Bayley Scales of Infant and Toddler Development Third edition | Each composite scores are summarized. The higher scores mean a better outcome. | 78 weeks after administration |
| The developmental quotient in Kyoto Scale of Psychological Development 2001 | The developmental quotient is summarized. The higher scores mean a better outcome. | 78 weeks after administration |
| Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words | Presence of each event is summarized. | at 26, 38, 52, and 78weeks after administration |
| Presence of spasticity | Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex. | at 12, 26, 38, 52, and 78 weeks after administration |
| Presence of epilepsy | Presence of spasticity is summarized. The definition of epilepsy is the condition based on the International League Against Epilepsy. | until 78 weeks after administration |
| MRI score | MRI score is summarized. The scoring system is based on the report of Barkovich AJ, et al. (AJNR Am J Neuroradiol. 1998 ;19(1):143-9.) . The higher scores mean a worse outcome. | at 2, and 78 weeks after administration |
| Gross Motor Function Classification System (GMFCS) score | GMFCS score is summarized. The gross motor function can be categorized into 5 different level. The higher scores mean a worse outcome. | at 78 weeks after administration |
| Matsuyama N, Shimizu S, Ueda K, Suzuki T, Suzuki S, Miura R, Katayama A, Ando M, Mizuno M, Hirakawa A, Hayakawa M, Sato Y. Safety and tolerability of a multilineage-differentiating stress-enduring cell-based product in neonatal hypoxic-ischaemic encephalopathy with therapeutic hypothermia (SHIELD trial): a clinical trial protocol open-label, non-randomised, dose-escalation trial. BMJ Open. 2022 Apr 26;12(4):e057073. doi: 10.1136/bmjopen-2021-057073. |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |