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ACT for CP Individual Patient Expanded Access IND Protocol

Primary Purpose

Cerebral Palsy

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Autologous Cord Blood Stem Cells
Sponsored by
Charles Cox
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Cerebral Palsy focused on measuring Autologous Cord Blood Stem Cells

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

-

Exclusion Criteria:

-

Sites / Locations

  • The University of Texas Health Science Center at Houston

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 22, 2017
Last Updated
May 12, 2020
Sponsor
Charles Cox
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1. Study Identification

Unique Protocol Identification Number
NCT03203941
Brief Title
ACT for CP Individual Patient Expanded Access IND Protocol
Official Title
Autologous Cell Therapies for Cerebral Palsy-Chronic (ACT for CP) Individual Patient Expanded Access IND Protocol
Study Type
Expanded Access

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Charles Cox

4. Oversight

5. Study Description

Brief Summary
Individual patient expanded access protocol for a child with cerebral palsy (CP) who has autologous umbilical cord blood available and who is ineligible to participate in other stem cell studies for children with CP.
Detailed Description
This protocol is part of an FDA Individual Patient Expanded Access IND submitted at the request of the parents of a child with cerebral palsy (CP) who is ineligible to participate in other stem cell studies. For this child, there are no other treatment options.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Autologous Cord Blood Stem Cells

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Autologous Cord Blood Stem Cells
Intervention Description
This is an individual patient expanded access protocol.

10. Eligibility

Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles S Cox, MD
Organizational Affiliation
UTHealth, McGovern Medical School at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

ACT for CP Individual Patient Expanded Access IND Protocol

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