Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy

Safety Issues Clinical Trial

Official title:

Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03791372
• Other study ID #: GuangdongWCHRD
• Status: Recruiting
• Phase: Phase 1
• Start date: October 10, 2017
• Est. completion date: April 10, 2021

Study information

• Verified date: January 2019
• Source: Guangdong Women and Children Hospital
• Contact: Xiao Huimei, MD
• Phone: +862039151772
• Email: xiaowu2010727[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of cerebral palsy.

Description:

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.

1. 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

2. Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.

3. 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.

4. The follow-up: clinical test until 30th month in 3 month gaps.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 10, 2021
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

Inclusion Criteria:

• A patient who was diagnosed with a mild case, and severity case of cerebral palsy or developmental disability through developmental assessment from more than two specialists including a specialist in pediatrics and rehabilitation medicine..

• In case there is a sign of the general decrease in white matter, or periventricular leukomalacia near cerebral ventricles in MRI DTI test.

• A subject who did a written consent to participation in this clinical trial through the very person and a legal representative.

Exclusion Criteria:

• In case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial.

• Accompanied by a serious disease, such as chromosome abnormality, etc.

• In case where a patient's medical condition is judged to be maladapted by a researcher.

• In case a patient or his or her legal representative doesn't agree to participation in a clinical trial.

• A patient having a predisposition to allergies.

• A patient having serious disorders in the liver, kidney, and cardiopulmonary function.

Related Conditions & MeSH terms

• Cerebral Palsy
• Effect of Drugs
• Safety Issues

Intervention

Drug:
• 0.9% Sodium Chloride
0.9% Sodium Chloride in control group

Biological:
• Autologous Umbilical Cord Blood
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.

Locations

Country	Name	City	State
China	Guangdong Women and Children's Hospital and Health Institute	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? represents the worst.	up to 30 months after therapy at a 3-month interval
Primary	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