Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05290662
Status:
RECRUITING
Last Update Posted:
2022-08-04
First Post:
2022-03-02
Brief Title:
Registry of Patients Having Received oNKord
Sponsor:
Glycostem Therapeutics BV
Organization:
Glycostem Therapeutics BV
Study Overview
Official Title:
A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord
Status:
RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ReKORD is an observational study Registry enrolling participants who have received at least one dose of oNKord allogeneic ex vivo-generated Natural Killer NK cells from CD34 umbilical cord blood progenitor cells in a clinical trial Participants from multiple previous clinical trials of oNKord can be enrolled in this Registry
Detailed Description:
To be eligible for this Registry participants must have received at least one dose of oNKord in a clinical trial Eligible participants will be enrolled after signing the informed consent form ICF Participant characteristics treatment history and clinical trial outcome data at clinical trial discontinuationcompletion will be collected On a yearly basis after the last clinical trial visit the investigator will collect the participants medical status and enter them in the Registry database Major clinical events including concomitant medication or therapy that occurred since the previous assessment will be recorded No protocol-specific visits or interventions will be required Participants will be followed up until 3 years after the first oNKord infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None