Effects of umbilical cord derived mesenchymal stem cells injection in the treatment of children with cerebral palsy

A Triple blinded, Parallel Randomized clinical trial Phase II&III of 3 Times Intrathecal Injections of an Umbilical Cord-Derived Mesenchymal Stromal Cell Product “WhartoCell” in Children with Cerebral Palsy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20110628006907N18

Enrollment

150

Registered

2023-03-11

Start date

2023-05-05

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Cerebral Palsy. Spastic quadriplegic cerebral palsy

Interventions

Intervention 1: Intervention group: CP patients receiving ?three intrathecal injection of 20 millions allogenic mesenchymal stem cells derived from umbilical cord (whartocell) , prepared by Cell Thec

Eligibility

Sex/Gender

All

Age

2 Years to 14 Years

Inclusion criteria

Inclusion criteria: Spastic cerebral palsy (Dip, Quadri, Hemiparetic ) Ages between 2 - 14 years Gross motor function classification (GMFC) 2 -4 No seizure disorder or with controlled seizure Acquired brain MRI finding compatible with CP Informed consent of parents

Exclusion criteria

Exclusion criteria: Normal brain MRI Progressive neurological diseases Congenital brain cortical malformations TORCH infections( Toxoplasmosis, Others, Rubella Cytomegalovirus Hepatitis C ) Other types of cerebral palsy (athetoid , atonic , ataxic , mixed ) Acute infections (Human Immunodeficiency Virus , Hepatitis C Virus ) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Severe renal dysfunction Severe liver dysfunction

Design outcomes

Primary

Measure	Time frame
Motor development alteration with GMFM 66 score. Timepoint: Before intervention , 3 months after first intervention ,6 months after first intervention , 12 months after first intervention. Method of measurement: GMFM 66 score Questionnaire.;Change of motor function with GMFCS score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: GMFCS Questionnaire.;Change of motor function according to PEDI score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: PEDI Questionnaire.;Change of motor function according to MACS score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: MACS Questionnaire.;Spasticity change of patients according to Ashworth scale. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: Ashworth Questionnaire.;Change of quality of life. Timepoint: Before intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: CPQOL Questionnaire.	—

Measure

Time frame

Motor development alteration with GMFM 66 score. Timepoint: Before intervention , 3 months after first intervention ,6 months after first intervention , 12 months after first intervention. Method of measurement: GMFM 66 score Questionnaire.;Change of motor function with GMFCS score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: GMFCS Questionnaire.;Change of motor function according to PEDI score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: PEDI Questionnaire.;Change of motor function according to MACS score. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: MACS Questionnaire.;Spasticity change of patients according to Ashworth scale. Timepoint: Before intervention, 3 months after first intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: Ashworth Questionnaire.;Change of quality of life. Timepoint: Before intervention, 6 months after first intervention, 12 months after first intervention. Method of measurement: CPQOL Questionnaire.

—

Secondary

Measure	Time frame
Probable Change of brain lesions. Timepoint: Before intervention, 1 year after first intervention. Method of measurement: Brain Magnetic Resonance Imaging (MRI), Brain Magnetic Resonance Spectroscopy (MRS), Brain Deep Tensor Imaging (DTI).;Number of participants experiencing adverse effects and serious adverse effects. Timepoint: First 24 hours after injection and then any time if occurred. Method of measurement: Questionnaire, parents report and periodic planned clinical evaluations.	—

Measure

Time frame

Probable Change of brain lesions. Timepoint: Before intervention, 1 year after first intervention. Method of measurement: Brain Magnetic Resonance Imaging (MRI), Brain Magnetic Resonance Spectroscopy (MRS), Brain Deep Tensor Imaging (DTI).;Number of participants experiencing adverse effects and serious adverse effects. Timepoint: First 24 hours after injection and then any time if occurred. Method of measurement: Questionnaire, parents report and periodic planned clinical evaluations.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAnahita Majmaa

Tehran University of Medical Sciences

majmaaa911@yahoo.com+98 21 6612 9252

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026