MedTrace Logo

Autologous Stem Cells for Spinal Cord Injury (SCI) in Children

NCT01328860 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-03-20

No results posted yet for this study

Summary

The purpose of this research study is:

1. To see if Bone Marrow Cell harvest and transplantation are safe in children with Spinal Cord Injury, and
2. To determine if late functional outcome is improved following Bone Marrow Cell transplantation in children with Spinal Cord Injury, using pre-transplantation spinal cord function as the control.

Conditions

  • Spinal Cord Injury

Interventions

BIOLOGICAL

bone marrow progenitor cells (BMPC) autologous transplantation

Not more than 5ml/kg bone marrow will be collected under anesthesia; after the bone marrow has been processed, about 6-8 hours after bone marrow aspiration, subjects will receive the cells via intra-venous (in the vein) infusion and will be monitored for 24 hours for any adverse events.

Sponsors & Collaborators

  • The Institute for Rehabilitaion and Research Foundation

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Baylor College of Medicine

    collaborator OTHER

  • Florida Hospital for Children

    collaborator OTHER

  • Aryn Knight

    lead OTHER

Principal Investigators

  • James E. Baumgartner, MD · MHHS, Houston,TX & FL Hospital for Children, Orlando, FL

  • Rex A. Marco, MD · University of Texas Health Science Center, Houston TX

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01328860 on ClinicalTrials.gov