Ignite Creation Date:
2024-07-17 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465160
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-02
Brief Title:
A Study to Evaluate the MNV-201 in Patients With Low Risk MDS
Sponsor:
Minovia Therapeutics Ltd
Organization:
Minovia Therapeutics Ltd
Study Overview
Official Title:
A Phase Ib Open Label Single Dose Clinical Study to Evaluate the Safety and Therapeutic Effects of Infusion of MNV-201 in Patients With Low Risk Myelodysplastic Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
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:
Myelodysplastic syndromes MDS are a group of bone marrow failures that occur when the blood-forming cells in the bone marrow become abnormal leading to an abnormal differentiation and production of one or more blood cell types According to the American Cancer Society in the United States MDS occurs at a rate of 48 cases for every 100000 people MDS affects an estimated 60000 persons in the United States with 10000-15000 new cases recorded each year MDS is defined by ineffective haematopoiesis resulting in blood cytopenias a reduction in the number of mature blood cells and clonal instability with a risk of evolution to acute myeloid leukaemia AML Patients with MDS collectively have a high symptom burden and are also at risk of death from complications of cytopenias and AML MDS is generally a disease that develops with ageing the median age at diagnosis of MDS is 70 years and patients frequently have comorbid conditions The goals of therapy for patients with MDS are to reduce disease-associated symptoms and the risk of disease progression and death thereby improving both quality and quantity of life
Minovia Therapeutics Ltd Minovia is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology MAT MNV-201 is a cell therapy produced by MAT that consists of the participants autologous CD34 hematopoietic stem and progenitor cells HSPCs enriched with allogeneic placental-derived mitochondria manufactured in Minovias GMP facility
Minovia Therapeutics Ltd Minovia is a biotech company developing novel therapeutics based on its mitochondrial augmentation technology MAT MNV-201 is a cell therapy produced by MAT that consists of the participants autologous CD34 hematopoietic stem and progenitor cells HSPCs enriched with allogeneic placental-derived mitochondria manufactured in Minovias GMP facility
Detailed Description:
None
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