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To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.
This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of cerebral palsy. The investigator will proceed the groups during the same period.
Demographic Data and Baseline Characteristics of the Studied Group were collected:
Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.
Autologous cord blood doses is 20-30ml (total Mononuclear cells>1*10^7/kg),the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo.
The follow-up: clinical test until 30th month in 3 month gaps.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min. |
|
| Cord Blood Mononuclear Cells(CBMNC) | Experimental | Autologous Umbilical Cord Blood Mononuclear Cells Therapy any time after the diagnosis of cerebral palsy, doses is 20-30ml (total Mononuclear cells>1*10^7/kg). The infusion speed is 1ml/min. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% Sodium Chloride | Drug | 0.9% Sodium Chloride in control group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Change of Gross Motor Function Classification System(GMFCS) Score | GMFCS is used to assess the gross motor function of the children who were diagnosised as cerebral palsy.The results of GMFCS are divided into five levels. Grade I represents the best outcome while grade â…¤ represents the worst. | up to 30 months after therapy at a 3-month interval |
| The Change of Gesell Developmental Scale(GDS) Score | The GDS is used to measure the gross motor,fine action,adaptability,language and individual-society function of the children whose age ranges from 1-month to 6-year-old. The score less than 75 for each subscale represent the worse outcome and more than 75 represent the better. | every 3-month after therapy until 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Huimei, MD | Contact | +862039151772 | +86 | xiaowu2010727@163.com |
| Chang Yanqun, Phd | Contact | +862039151772 | +86 | sfycyq@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Yanqun, Phd | Guangdong Women and Children Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Women and Children's Hospital and Health Institute | Recruiting | Guangzhou | Guangdong | 510010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29080265 | Background | Sun JM, Song AW, Case LE, Mikati MA, Gustafson KE, Simmons R, Goldstein R, Petry J, McLaughlin C, Waters-Pick B, Chen LW, Wease S, Blackwell B, Worley G, Troy J, Kurtzberg J. Effect of Autologous Cord Blood Infusion on Motor Function and Brain Connectivity in Young Children with Cerebral Palsy: A Randomized, Placebo-Controlled Trial. Stem Cells Transl Med. 2017 Dec;6(12):2071-2078. doi: 10.1002/sctm.17-0102. Epub 2017 Oct 28. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Parallel assignment
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| Autologous Umbilical Cord Blood |
| Biological |
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation. |
|
|
| D017670 |
| Sodium Compounds |