UCB Therapy in Acquired Brain Injury

M

MinYoung Kim, M.D.

Status and phase

Completed
Phase 1

Conditions

Acquired Brain Injury

Treatments

Procedure: Umbilical cord blood therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01885663
UCBABI

Details and patient eligibility

About

This open label trial is conducted to investigate the efficacy and safety of allogeneic umbilical cord blood (UCB) therapy for patients with acquired brain injury.

Full description

Acquired brain injury (ABI) means brain damage caused by events after birth, rather than as part of a genetic or congenital disorders. Those with ABI suffer from cognitive, physical, or behavioral impairments limiting their activity and participation in society. ABI results from traumatic or non-traumatic brain injury due to internal or external source (e.g. infection, brain tumor, hypoxia). Preclinical studies regarding cell therapy in animal models of ABI showed improvements of neurological dysfunction. UCB possess various stem or progenitor cells and is known to secrete neurotrophic factors to repair injured brain. This clinical research aims to determine the safety and efficacy of allogeneic UCB for patients with ABI.

Enrollment

3 patients

Sex

All

Ages

5 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Acquired brain injury * Duration: over 12 months * Willing to comply with all study procedure

Exclusion criteria

* Medical instability including pneumonia or renal function at enrollment * Uncontrolled persistent epilepsy * Poor cooperation of guardian,including inactive attitude for rehabilitation and visits for follow-up * Not eligible according to the principal investigator

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

Umbilical cord blood therapy
Experimental group
Description:
Umbilical cord blood therapy
Treatment:
Procedure: Umbilical cord blood therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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