The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05598775
Recruitment Status : Enrolling by invitation
First Posted : October 28, 2022
Last Update Posted : October 28, 2022
Sponsor:
Information provided by (Responsible Party):
ReNeuron Limited
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Brief Summary:
The purpose of this long-term safety study is to follow up subjects treated with CTX0E03 DP to monitor for delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival
Ischemic Stroke
Other: Non Interventional long term safety follow up
Detailed Description:
The goal of this study is to assess the long-term safety of subjects treated with intracerebral CTX0E03 DP as measured by the onset of delayed adverse events of special interest (AESIs). AESIs are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the Safety/Project Physician is related to CTX0E03 DP.
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Study Type :
Observational
Estimated Enrollment :
9 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Phase 2b Study
Estimated Study Start Date :
November 1, 2022
Estimated Primary Completion Date :
November 1, 2026
Estimated Study Completion Date :
December 31, 2026
Resource links provided by the National Library of Medicine
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Intervention Details:
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Primary Outcome Measures :
Long-term safety study is to follow up subjects treated with CTX0E03 DP [ Time Frame: 4 Years ]
Identify delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival.
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
35 Years to 75 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study
Inclusion Criteria:
Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent
Exclusion Criteria:
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05598775
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Amy Miller, RPh, PharmD
Morgantown, West Virginia, United States, 26505
ReNeuron Limited
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Responsible Party:
ReNeuron Limited
ClinicalTrials.gov Identifier:
NCT05598775 Â Â
Other Study ID Numbers:
RN01-CP-0004
First Posted:
October 28, 2022 Â Â Key Record Dates
Last Update Posted:
October 28, 2022
Last Verified:
October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
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Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
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Ischemic StrokeStrokeCerebrovascular DisordersBrain Diseases
Central Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
