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

Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic and mesenchymal stem cells on developmental functions of spastic cerebral palsy patients between 4-14 years old in comparison with control group , A Clinical trial phase II

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201706176907N13
Enrollment
108
Registered
2017-07-12
Start date
2017-11-22
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Spastic Cerebral Palsy. Cerebral Palsy , Unspecified

Interventions

Intervention 1: Intervention group 1 one intrathecal injection of hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg ) prepared by Royan stem cell Technology Company . Intrat

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
ROYAN stem cell technology Co
Collaborator
Welfare Organization of Iran
Collaborator
Hormozgan University of Medical Sciences
Collaborator

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: Spastic cerebral palsy (Diparetic , Quadriparetic) Ages between 4 - 14 years Gross motor function classification (GMFC) between 2 -5 No seizure disorder or with controlled seizure Evidence of definite acquired abnormal imaging findings compatible with Cerebral Palsy Informed consent taken from their parents

Exclusion criteria

Exclusion criteria: Normal brain MRI Progressive neurological diseases ( for example leukodystrophy or neurometabolic disorders) Congenital Cortical malformations Toxoplasmosis Others Rubella Cytomegalovirus Hepatitis (TORCH) infections Other types of cerebral palsy including athetoid , atonic , ataxic , and mixed type Acute intercurrent infections such as Hepatitis C Virus ( HCV), Hepatitis B Virus (HBV) ,Human Immunodeficiency Virus (HIV) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Renal insufficiency Severe liver dysfunction

Design outcomes

Primary

MeasureTime frame
Motor development alteration with GMFM 66 score. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.;Change of motor function with GMFCS score. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.;Spasticity change of patients according to Ashworth scale. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.;Developmental status according to Stanford Binet test. Timepoint: Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention. Method of measurement: questionairre.

Secondary

MeasureTime frame
Probable Change of brain lesions. Timepoint: Before intervention , 1 year after intervention. Method of measurement: Brain Magnetic Resonance Imaging (MRI) , Brain Magnetic Resonance Spectroscopy (MRS) , Brain Deep Tensor Imaging (DTI).;Fever. Timepoint: 24 hours after intervention , 48 hours after intervention , 72 hours after intervention. Method of measurement: Axillary thermometer.;Meningitis. Timepoint: First 3 days after intervention or any time after intervention. Method of measurement: Lumbar Puncture.;Hyper sensitivity reactions. Timepoint: First week after intervention. Method of measurement: Physical exam.

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: May 21, 2026