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

Guangdong Women and Children Hospital

Status and phase: Unknown; Phase 1

Conditions: Effect of Drugs; Safety Issues

Treatments: Drug: 0.9% Sodium Chloride; Biological: Autologous Umbilical Cord Blood

Study type: Interventional

Funder types: Other

Identifiers

NCT03791372

GuangdongWCHRD

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 6 months to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.

Treatment:

Drug: 0.9% Sodium Chloride

Cord Blood Mononuclear Cells(CBMNC)

Experimental group

Description:

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.

Treatment:

Biological: Autologous Umbilical Cord Blood