Umbilical Cord Blood Therapy for Global Developmental Delay

MinYoung Kim, M.D.

Status: Completed

Conditions: Global Developmental Delay

Treatments: Procedure: Umbilical cord blood transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT01769716

UCBGDD

Details and patient eligibility

About

This open-label study aims to evaluate the safety and efficacy of autologous or allogeneic umbilical cord blood therapy for children with global developmental delay.

Full description

Global developmental delay is defined as significant delay in two or more of the following developmental domains: gross/fine motor, speech/language, cognition, social/personal, and activities of daily living.

Umbilical cord blood has been used for inherited metabolic diseases that feature global developmental delay and many experimental animal studies have revealed umbilical cord blood is useful to repair neurological impairments in brain.

Enrollment: 14 patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Global developmental delay
• Willing to comply with all study procedure

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Umbilical cord blood transplantation

Experimental group

Description:

Allogeneic umbilical cord blood will be administered intravenously or intraarterially under non-myeloablative immunosuppression. In case of autologous umbilical cord blood, immunosuppression is not required.

Treatment:

Procedure: Umbilical cord blood transplantation