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
About this trial
This is an expanded access trial for Cerebral Palsy focused on measuring Autologous Cord Blood Stem Cells
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
- The University of Texas Health Science Center at Houston
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
We'll reach out to this number within 24 hrs