Umbilical Cord Blood Therapy for Global Developmental Delay

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Global Developmental Delay

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

allogeneic cord blood transplantation for children with developmental delay

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Umbilical cord blood transplantation

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.

Group Type EXPERIMENTAL

Umbilical cord blood transplantation

Intervention Type PROCEDURE

Interventions

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Umbilical cord blood transplantation

Intervention Type PROCEDURE

Other Intervention Names

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Autologous or Allogeneic Umbilical Cord Blood

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No