Cerebral PalsyNCT03203941
ACT for CP Individual Patient Expanded Access IND Protocol
A study testing Autologous Cord Blood Stem Cells in people with Cerebral Palsy, run by Charles Cox at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Autologous Cord Blood Stem Cells
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Autologous Cell Therapies for Cerebral Palsy-Chronic (ACT for CP) Individual Patient Expanded Access IND Protocol
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Autologous Cord Blood Stem Cells
- Keywords
- Autologous Cord Blood Stem Cells
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Cord Blood Stem CellsBiological
This is an individual patient expanded access protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Charles Cox
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charles Cox, The University of Texas Health Science Center, Houston
- Investigators
- Charles S Cox, MD, Principal investigator, UTHealth, McGovern Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203941
- Sponsor's protocol ID
- HSC-MS-17-0529
- Status last verified
- May 2020
- First submitted
- 22 Jun 2017
- Last updated
- 13 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cell Therapies for Cerebral Palsy-Chronic (ACT for CP) Individual Patient Expanded Access IND Protocol
- ClinicalTrials.gov ID
- NCT03203941
- Acronym / sponsor ID
- HSC-MS-17-0529
- Conditions
- Cerebral Palsy
- Keywords
- Autologous Cord Blood Stem Cells
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Charles CoxUniversity, hospital or other
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Cord Blood Stem CellsThis is an individual patient expanded access protocol. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles S Cox, MD principal investigator
UTHealth, McGovern Medical School at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Cord Blood Stem Cells in people with Cerebral Palsy, run by Charles Cox at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.