Stem Cell and Conditioned Medium for Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04314687
• Other study ID #: CT/CP/02/2020
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 13, 2021
• Est. completion date: December 25, 2023

Study information

• Verified date: June 2022
• Source: PT. Prodia Stem Cell Indonesia
• Contact: Hardiono D. Pusponegoro
• Phone: 088293176579
• Email: hardionodp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 25, 2023
• Est. primary completion date: September 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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.
• 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:
• Standard Therapy
Standard therapy for cerebral palsy such as physiotherapy

Locations

Country	Name	City	State
Indonesia	Indonesian National Brain Center	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT. Prodia Stem Cell Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function	Gross Motor Function Classification System (GMFCS)	3 month after stem cells
Primary	Gross Motor Function	Gross Motor Function Classification System (GMFCS)	6 month after stem cells
Primary	Gross Motor Function	Gross Motor Function Measure (GMFM)	3 month after stem cells
Primary	Gross Motor Function	Gross Motor Function Measure (GMFM)	6 month after stem cells
Primary	Cognitive Function	Bayley Scales of Infant Development (BSID) version III	3 month after stem cells
Primary	Cognitive Function	Bayley Scales of Infant Development (BSID) version III	6 month after stem cells
Secondary	Chemical Marker	Insulin-like growth factor 1 (IGF-1); stromal derived factor-1a (SDF-1a); 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
Secondary	Chemical Marker	Insulin-like growth factor 1 (IGF-1); stromal derived factor-1a (SDF-1a); 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