Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469729
Status:
COMPLETED
Last Update Posted:
2015-07-10
First Post:
2007-05-03
Brief Title:
Efficacy and Safety Study of StemEx to Treat Subjects With High Risk Hematologic Malignancies Following Myeloablative Therapy
Sponsor:
Gamida Cell -Teva Joint Venture Ltd
Organization:
Gamida Cell -Teva Joint Venture Ltd
Study Overview
Official Title:
A Multi-Center Multi-National Historical Cohort Controlled Study to Evaluate Efficacy and Safety of Transplantation of StemEx Umbilical Cord Blood Stem and Progenitor Cells Expanded Ex Vivo in Subjects With Hematologic Malignancies Following Myeloablative Therapy
Status:
COMPLETED
Status Verified Date:
2013-03
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:
ExCell
Brief Summary:
The purpose of this study is to determine the efficacy and safety of transplanting StemEx in patients with certain hematological malignancies For these patients it is suggested that StemEx can improve upon the outcome of transplanting a single unmanipulated cord blood unit by significantly increasing the number of stemprogenitor cells available to the patient
Detailed Description:
Allogeneic hematopoietic stem cell transplantation is a life-saving procedure for patients with hematologic malignancies yet wide application of this procedure is limited by the availability of suitably Human Leukocyte Antigen HLA - matched donors Only 30 of patients who could benefit from this procedure have an HLA-matched sibling The lengthy search for a matched donor may critically delay transplantation In addition far fewer patients of racial minorities find suitable HLA-matched donors Umbilical cord blood UCB has been increasingly used as an alternative source of stem cells however its use in adults and adolescent patients is limited due to insufficient cell dose required for satisfactory hematopoietic reconstitution
Gamida Cell - Teva Joint Venture Ltd is engaged in the development of StemEx an expanded hematopoietic UCB stem cell graft as a potential medicinal product for the treatment of cancer and hematological malignancies The expansion technology enables preferential expansion of hematopoietic stem and early progenitor cells and is based on the findings that copper chelators can regulate the balance between self-renewal and differentiation of stem cells
The multi-national multi-center Phase IIIII clinical study designated to evaluate the safety and efficacy of StemEx will enroll approximately 100 subjects with high-risk hematologic malignancies who are candidates for allogeneic stem cell transplantation SCT This study will evaluate the effect of StemEx on overall survival as measured by overall 100-day mortality
The study consists of 4 phases
1 Screening phase includes subjects clinical assessment and screening tests
2 Conditioning phase includes the myeloablative treatment prior transplantation procedure
3 Transplantation and post-transplant follow-up phase to day 180
4 Observational phase survival status follow-up to day 730 18 months
Gamida Cell - Teva Joint Venture Ltd is engaged in the development of StemEx an expanded hematopoietic UCB stem cell graft as a potential medicinal product for the treatment of cancer and hematological malignancies The expansion technology enables preferential expansion of hematopoietic stem and early progenitor cells and is based on the findings that copper chelators can regulate the balance between self-renewal and differentiation of stem cells
The multi-national multi-center Phase IIIII clinical study designated to evaluate the safety and efficacy of StemEx will enroll approximately 100 subjects with high-risk hematologic malignancies who are candidates for allogeneic stem cell transplantation SCT This study will evaluate the effect of StemEx on overall survival as measured by overall 100-day mortality
The study consists of 4 phases
1 Screening phase includes subjects clinical assessment and screening tests
2 Conditioning phase includes the myeloablative treatment prior transplantation procedure
3 Transplantation and post-transplant follow-up phase to day 180
4 Observational phase survival status follow-up to day 730 18 months
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