Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CHA University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic umbilical cord blood therapy for children with global developmental delay.
Global developmental delay is defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.
Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord blood transplantation | Experimental | Allogeneic umbilical cord blood will be administered intravenously or intraarterially under non-myeloablative immunosuppression. In case of autologous umbilical cord blood, immunosuppression is not required. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord blood transplantation | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Cognition | Korean Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI) (Higher value means better cognitive function (K-WPPSI: below 70 - worst, over 130 - best) | Baseline - 6 months - 12 months |
| Changes in Cognitive Neurodevelopmental Outcome | Korean version of Bayley Scale of Infant Development-II Mental Scales (Higher value means better cognitive function: raw score 0 - worst, 178 - best.) | Baseline - 1 month - 3 months - 6 months - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Motor Performance | GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0~100, Higher value means better motor quality.) | Baseline - 1 month - 3 months - 6 months - 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MinYoung Kim, M.D., Ph.D. | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36734415 | Derived | Cha B, Kwak H, Bang JI, Jang SJ, Suh MR, Choi JI, Kim M. Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy for Global Development Delay and Intellectual Disability. Stem Cells Dev. 2023 Apr;32(7-8):170-179. doi: 10.1089/scd.2022.0252. Epub 2023 Mar 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D036101 | Cord Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
Not provided
Not provided
allogeneic cord blood transplantation for children with developmental delay
Not provided
Not provided
Not provided
Not provided
| Changes in Standardized Gross Motor Function | GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function.) | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Motor Neurodevelopmental Outcome | Korean version of Bayley Scale of Infant Development-II Motor Scales (Higher value means better motor function: raw score 0 - worst, 112 - best) | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Functional Independence in Daily Activities | WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Visual Perception Test | Visual perception function is evaluated with one of three measures: DTVP (Developmental Test of Visual Perception), MVPT (Motor-free Visual Perception Test), and VMI (Visual-Motor Integration). All can be scored as percentile rank from 0 to 100. Higher values mean better visual perception ability. | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Muscle Strength | Summation of MMT (manual muscle testing): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 ~ 160). Higher scores mean better muscle strength. | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Functional Performance in Daily Activities | Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best.) | Baseline - 1 month - 3 months - 6 months - 12 months |
| Changes in Language Evaluation | Sequenced Language Scale for Infant (SELSI), Preschool Receptive-Expressive Language Scale (PRES) or Korean Western Aphasia Battery (K-WAB) | Baseline - 6 months - 12 months |
| Changes in Brain glucose metabolism | FDG-PET | Baseline - 12 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |