Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01816230
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2013-03-19
Brief Title:
Transplantation of NiCord Umbilical Cord Blood-derived Ex Vivo Expanded Cells in Patients With HM
Sponsor:
Gamida Cell ltd
Organization:
Gamida Cell ltd
Study Overview
Official Title:
Allogeneic Stem Cell Transplantation of NiCord Umbilical Cord Blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Adolescent and Adult Patients With Hematological Malignancies
Status:
COMPLETED
Status Verified Date:
2020-10
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:
A Study Evaluating the Safety and Efficacy of Transplantation of a single cord blood unit CBU of NiCord umbilical cord blood-derived Ex Vivo Expanded Stem and Progenitor Cells in Patients with Hematological Malignancies
Detailed Description:
Umbilical cord blood UCB is an alternative stem cell source for hematopoietic stem cell transplantations HSCT and can be used for the treatment of various life-threatening diseases such as hematological malignancies or genetic blood disorders in such cases where a matched related stem cell donor is not available However the major drawback of using this valuable stem cells source is the limited cell dose in a single cord blood unit CBU which was shown to be associated with inadequate hematopoietic reconstitution and high risk of transplant-related mortality To improve outcomes and extend applicability of UCB transplantation one potential solution is ex vivo expansion of UCB-derived stem and progenitor cells NiCord is a stemprogenitor cell based product composed of ex vivo expanded allogeneic UCB cells NiCord is based on a novel technology for the ex vivo cell expansion of cord blood derived hematopoietic progenitor cells By increasing the number of the short and long-term reconstitution progenitor cells transplanted NiCord has the potential to enable the broader application of UCB transplantation and improve the clinical outcomes of UCB transplantation
The study is designed as a multi center single arm study evaluating the safety and efficacy of the transplantation of NiCord to patients with hematological malignancies following myeloablative therapy
Total study duration is approximately 400 days from the signing of informed consent to the last visit one year following transplantation
The overall study objective is to evaluate the safety and efficacy of NiCord single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy as follows
The main study objectives are to assess the cumulative incidence of patients with NiCord-derived neutrophil engraftment at 42 days following transplantation and to assess the incidence of secondary graft failure at 180 days following transplantation of NiCord Ten evaluable patients recruited for the study should be 12-65 years of age up to a maximum of 15 treated patients
The study is designed as a multi center single arm study evaluating the safety and efficacy of the transplantation of NiCord to patients with hematological malignancies following myeloablative therapy
Total study duration is approximately 400 days from the signing of informed consent to the last visit one year following transplantation
The overall study objective is to evaluate the safety and efficacy of NiCord single ex-vivo expanded cord blood unit transplantation in patients with hematological malignancies following myeloablative therapy as follows
The main study objectives are to assess the cumulative incidence of patients with NiCord-derived neutrophil engraftment at 42 days following transplantation and to assess the incidence of secondary graft failure at 180 days following transplantation of NiCord Ten evaluable patients recruited for the study should be 12-65 years of age up to a maximum of 15 treated patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None