A First in Human Study to Evaluate the Safety of Infusion of MNV-BM-PLC (Autologous CD34+ Cells Enriched With Placenta Derived Allogeneic Mitochondria) in Patients With Primary Mitochondrial Diseases Associated With Mitochondrial DNA Mutation or Deletion

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 1, 2022

Primary Completion Date

December 1, 2024

Study Completion Date

December 1, 2024

Conditions
Primary Mitochondrial Diseases
Interventions
PROCEDURE

Bone Marrow mobilization

"During four days before the apheresis, Neupogen (G-CSF) at a dose of 10 microgram per kilogram will be administered subcutaneously in the morning (days -6 to -3 of cell therapy). In addition, Mozobil (Plerixafor) at a dose of 0.24 milligram per kilogram will be administered subcutaneously approximately 4 hours before apheresis initiation.~A fifth dose of Neupogen (G-CSF) will be administered just prior to the apheresis"

PROCEDURE

Apheresis

Apheresis will be performed two days prior to MNV-BM-PLC infusion. During this procedure, patient's peripheral blood will be collected by apheresis

BIOLOGICAL

MNV-BM-PLC infusion

"The MNV-BM-PLC (autologous CD34+ cells enriched with placenta-derived allogeneic mitochondria) infusion will be performed by standard IV procedure.~The dosing interval between patients will be at minimum 2 weeks."

Trial Locations (1)

Unknown

Sheba Medical Center - Tel Ashomer, Ramat Gan

Sponsors
All Listed Sponsors
lead

Minovia Therapeutics Ltd.

INDUSTRY

NCT04548843 - A First in Human Study to Evaluate the Safety of Infusion of MNV-BM-PLC (Autologous CD34+ Cells Enriched With Placenta Derived Allogeneic Mitochondria) in Patients With Primary Mitochondrial Diseases Associated With Mitochondrial DNA Mutation or Deletion | Biotech Hunter | Biotech Hunter