Stem Cell and Conditioned Medium for Cerebral Palsy

June 12, 2022 updated by: PT. Prodia Stem Cell Indonesia

Allogeneic Umbilical Cord Mesenchymal Stem Cells and Conditioned Medium for Cerebral Palsy in Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • Indonesian National Brain Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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, blood sampling collection and observation for their child

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 or neuroregeneratif disease
  • Progressive disorder
  • Regressive development disorder
  • Severe anatomical abnormalities in Brain MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCMSCs + CM
UCMSCs + CM is administered via intrathecal injection
Biological: Umbilical Cord Mesenchymal Stem Cells
The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
Other Names:
  • Allogeneic Mesenchymal Stem Cells
Biological: Conditioned Medium
Conditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product.
Other Names:
  • Umbilical Cord Mesenchymal Stem Cells derived Conditioned Medium
Experimental: UCMSCs
UCMSCs is administered via intrathecal injection
Biological: Umbilical Cord Mesenchymal Stem Cells
The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
Other Names:
  • Allogeneic Mesenchymal Stem Cells
Active Comparator: Standard Therapy
Physiotherapy
Other: Standard Therapy
Standard therapy for cerebral palsy such as physiotherapy
Other Names:
  • Physiotheraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function
Time Frame: 3 month after stem cells
Gross Motor Function Classification System (GMFCS)
3 month after stem cells
Gross Motor Function
Time Frame: 6 month after stem cells
Gross Motor Function Classification System (GMFCS)
6 month after stem cells
Gross Motor Function
Time Frame: 3 month after stem cells
Gross Motor Function Measure (GMFM)
3 month after stem cells
Gross Motor Function
Time Frame: 6 month after stem cells
Gross Motor Function Measure (GMFM)
6 month after stem cells
Cognitive Function
Time Frame: 3 month after stem cells
Bayley Scales of Infant Development (BSID) version III
3 month after stem cells
Cognitive Function
Time Frame: 6 month after stem cells
Bayley Scales of Infant Development (BSID) version III
6 month after stem cells

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemical Marker
Time Frame: 3 month after stem cells
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
3 month after stem cells
Chemical Marker
Time Frame: 6 month after stem cells
Insulin-like growth factor 1 (IGF-1); stromal derived factor-1α (SDF-1α); brain derived neurotrophic factors (BDNF), Vascular endothelial growth factor (VEGF),glial cell line-derived neutrophic factor (GDNF), fibroblast growth factor (FGF), Doublecortin (DCX)
6 month after stem cells

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2021

Primary Completion (Anticipated)

September 25, 2023

Study Completion (Anticipated)

December 25, 2023

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 12, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/CP/02/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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