Stem Cell and Conditioned Medium for Cerebral Palsy

Last updated: June 12, 2022
Sponsor: PT. Prodia Stem Cell Indonesia
Overall Status: Active - Recruiting

Phase

1/2

Condition

Cerebral Palsy

Cataplexy

Treatment

N/A

Clinical Study ID

NCT04314687
CT/CP/02/2020
  • Ages 6-3
  • All Genders

Study Summary

The aim of this study was to compare the effectiveness of umbilical cord mesenchymal stem cells (UCMSCs) and conditioned medium (CM) administration, UCMSCs only and control with standard therapy.

Hypothesis: UCMSCs + CM therapy resulting in higher improvement in cognitive function, gross motor function and chemical factors than UCMSCs and standard therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed as Cerebral palsy with total body involvement type
  • Age between 6 month - 3 years old
  • Parents requesting for cell therapy
  • The parents give sign in informed consent form do to examination, therapy, bloodsampling collection and observation for their child

Exclusion

Exclusion Criteria:

  • Head circumference less than -3 SD (more than 3 cm) Nellhaus standard
  • Have diagnosed meningitis and encephalitis
  • Have diagnosed congenital infection i.e. toxoplasmosis, rubella congenital,cytomegalovirus
  • Have diagnosed metabolic disorder, chromosome disorder, congenital malformation orneuroregeneratif disease
  • Progressive disorder
  • Regressive development disorder
  • Severe anatomical abnormalities in Brain MRI

Study Design

Total Participants: 78
Study Start date:
October 13, 2021
Estimated Completion Date:
December 25, 2023

Connect with a study center

  • Indonesian National Brain Center

    Jakarta,
    Indonesia

    Active - Recruiting

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