Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy
|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: NCT03791372|
Recruitment Status : Recruiting
First Posted : January 1, 2019
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues Effect of Drugs||Drug: 0.9% Sodium Chloride Biological: Autologous Umbilical Cord Blood||Phase 1|
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:
- Basic patient's information survey
- Medical history
- Physical examination
- Basic blood test result
- Children's developmental disorders evaluation before the treatment
- Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRI-DTI) before the treatment
- Neurocognitive function test before the treatment
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy|
|Actual Study Start Date :||October 10, 2017|
|Estimated Primary Completion Date :||October 10, 2020|
|Estimated Study Completion Date :||April 10, 2021|
Placebo Comparator: Placebo
0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
Drug: 0.9% Sodium Chloride
0.9% Sodium Chloride in control group
Experimental: Cord Blood Mononuclear Cells(CBMNC)
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.
Biological: Autologous Umbilical Cord Blood
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.
Other Name: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
- The Change of Gross Motor Function Classification System(GMFCS) Score [ Time Frame: up to 30 months after therapy at a 3-month interval ]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 Ⅴ represents the worst.
- The Change of Gesell Developmental Scale(GDS) Score [ Time Frame: every 3-month after therapy until 30 months ]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.
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): NCT03791372
|Contact: Xiao Huimei, MD||+862039151772 ext +email@example.com|
|Contact: Chang Yanqun, Phd||+862039151772 ext +firstname.lastname@example.org|
|Guangdong Women and Children's Hospital and Health Institute||Recruiting|
|Guangzhou, Guangdong, China, 510010|
|Contact: Chang Yanqun, Phd +862039151772 email@example.com|
|Study Director:||Chang Yanqun, Phd||Guangdong Women and Children Hospital|