The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy (SHIELD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04261335|
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : March 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypoxia-Ischemia, Brain||Biological: CL2020 cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||3 + 3 dose escalation study design|
|Masking:||None (Open Label)|
|Official Title:||The Evaluation of Safety and Tolerability of CL2020 in Neonatal Hypoxic Ischemic Encephalopathy Patients With Therapeutic Hypothermia in the Dose Escalation Clinical Trial|
|Actual Study Start Date :||March 4, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||September 2023|
Experimental: CL2020 cells
Intravenous injection of CL2020 cells
Biological: CL2020 cells
1.5 million or 15 million cells, IV on day 5 to 14 of birth
- Incidence of adverse events [ Time Frame: until 12 weeks after the administration ]Any adverse events are summarized.
- Incidence of composite endpoints (death, continuous respiratory support, and continuous use of vasopressors or pulmonary vasodilators) [ Time Frame: at 12, 26, 38, 52, and 78 weeks after administration ]Incidence of composite endpoints is summarized.
- Mortality [ Time Frame: all of the clinical trial period (up to 44 months) ]Mortality is summarized.
- Overall survival [ Time Frame: all of the clinical trial period (up to 44 months) ]Overall survival is summarized.
- Duration of continuous respiratory support [ Time Frame: up to 78 weeks ]Duration of continuous respiratory support is summarized.
- Duration of continuous use of vasopressors or pulmonary vasodilators [ Time Frame: up to 78 weeks ]Duration of continuous use of vasopressors or pulmonary vasodilators is summarized.
- 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 [ Time Frame: 78 weeks after administration ]Each composite scores are summarized. The higher scores mean a better outcome.
- The developmental quotient in Kyoto Scale of Psychological Development 2001 [ Time Frame: 78 weeks after administration ]The developmental quotient is summarized. The higher scores mean a better outcome.
- Presence of 1) head control, 2) roll over, 3) sitting position, 4) crawl, 5) independent gait, and 6) meaningful words [ Time Frame: at 26, 38, 52, and 78weeks after administration ]Presence of each event is summarized.
- Presence of spasticity [ Time Frame: at 12, 26, 38, 52, and 78 weeks after administration ]Presence of spasticity is summarized. Spasticity is the condition as below: increased muscle tone, or increased deep tendon reflex.
- Presence of epilepsy [ Time Frame: until 78 weeks after administration ]Presence of spasticity is summarized. The definition of epilepsy is the condition based on the International League Against Epilepsy.
- MRI score [ Time Frame: at 2, and 78 weeks after administration ]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.
- Gross Motor Function Classification System (GMFCS) score [ Time Frame: at 78 weeks after administration ]GMFCS score is summarized. The gross motor function can be categorized into 5 different level. The higher scores mean a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261335
|Contact: Yoshiaki Sato, MD, PhDfirstname.lastname@example.org|
|Contact: Kazuto Ueda, MDemail@example.com|
|Nagoya University Hospital||Recruiting|
|Nagoya, Aich, Japan, 466-8560|
|Contact: Yoshiaki Sato, MD, Ph.D +81-52-741-2985 firstname.lastname@example.org|
|Principal Investigator:||Yoshiaki Sato, MD, PhD||Department of Center for Maternal Neonatal Care, Nagoya University Hospital|