Stem Cell and Conditioned Medium for Cerebral Palsy

PT. Prodia Stem Cell Indonesia

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Cerebral Palsy

Treatments: Biological: Conditioned Medium; Biological: Umbilical Cord Mesenchymal Stem Cells; Other: Standard Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04314687

CT/CP/02/2020

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: All

Ages: 6 months to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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78 participants in 3 patient groups

UCMSCs + CM

Experimental group

Description:

UCMSCs + CM is administered via intrathecal injection

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells

Biological: Conditioned Medium

UCMSCs

Experimental group

Description:

UCMSCs is administered via intrathecal injection

Treatment:

Biological: Umbilical Cord Mesenchymal Stem Cells

Standard Therapy

Active Comparator group

Description:

Physiotherapy

Treatment:

Other: Standard Therapy