Microscopic image showing a nuclear genome being removed from a donor egg (oocyte). Who is eligible? Women who carry known harmful mtDNA mutations ages 18-37 years-old. What is the cost? Study-related procedures will be covered by the project. Travel-related expenses may be covered. Contact Information About Us Columbia University Medical Center has internationally renowned experts in mitochondrial disease, stem cell biology, and IVF who are collaborating in this important research project to assess safety and feasibility of OMR. Investigators include Dr. Rogerio Lobo, MD, Dr. Dieter Egli, PhD, and Dr. Michio Hirano, MD. Contact Us Dr. Michio Hirano or Ms. Kristin Engelstad MS CGC Phone: 1-212-305-6834 Email: [email protected] The Columbia Oocyte Mitochondrial Replacement Study (COMRS) Investigating Oocyte Mitochondrial Replacement (OMR) to prevent transmission of mitochondrial DNA mutations COLUMBIA UNIVERSITY MEDICAL CENTER IRB-AAAM3550 for use until: 02/14/2018 IRB Approval Date: 02/15/2017

COLUMBIA UNIVERSITY MEDICAL - The United Mitochondrial ......Mitochondrial Replacement Study (COMRS) Investigating Oocyte Mitochondrial Replacement mitochondrial DNA mutations COLUMBIA

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Page 1: COLUMBIA UNIVERSITY MEDICAL - The United Mitochondrial ......Mitochondrial Replacement Study (COMRS) Investigating Oocyte Mitochondrial Replacement mitochondrial DNA mutations COLUMBIA

Microscopicimageshowinganucleargenomebeingremovedfromadonoregg(oocyte).

Whoiseligible?

WomenwhocarryknownharmfulmtDNAmutationsages18-37years-old.

Whatisthecost?

Study-relatedprocedureswillbecoveredbytheproject.Travel-relatedexpensesmaybecovered.

ContactInformation

AboutUs

ColumbiaUniversityMedicalCenterhasinternationallyrenownedexpertsinmitochondrialdisease,stemcellbiology,andIVFwhoarecollaboratinginthisimportantresearchprojecttoassesssafetyandfeasibilityofOMR.InvestigatorsincludeDr.RogerioLobo,MD,Dr.DieterEgli,PhD,andDr.MichioHirano,MD.

ContactUs

Dr.MichioHiranoorMs.KristinEngelstadMSCGC

Phone:1-212-305-6834Email:[email protected]

TheColumbiaOocyteMitochondrialReplacementStudy(COMRS)

InvestigatingOocyteMitochondrialReplacement(OMR)topreventtransmissionofmitochondrialDNAmutations

COLUMBIAUNIVERSITYMEDICALCENTER

IRB-AAAM3550

for use until: 02/14/2018IRB Approval Date: 02/15/2017

Page 2: COLUMBIA UNIVERSITY MEDICAL - The United Mitochondrial ......Mitochondrial Replacement Study (COMRS) Investigating Oocyte Mitochondrial Replacement mitochondrial DNA mutations COLUMBIA

Whataremitochondriaandmitochondrialdiseases?Oftendescribedasthepowerhousesofcells,mitochondriaareessentialcellularcomponentsthatproduceenergy.Virtuallyeverycellinourbodiescontainmitochondria,whichhavetheirownDNA:mitochondrialDNA(mtDNA),whichisuniqueandseparatefromnuclearDNA(nDNA).MutationsineithermtDNAornDNAcandisruptmitochondrialfunctionsleadingtodiversediseasesthatoftenaffectmultipleorgans.

UnderstandingmtDNAmutationsBecausemtDNAsarepresentinhundredsorthousandsofcopiespercell,theproportion(heteroplasmy)ofmutantmtDNAcanvarywidelyandcandictatetheseverityofapatient’smitochondrialdisease.AnotherspecialpropertyofmtDNAisitsmaternalinheritance;onlymotherspassontheirmtDNAtotheirchildren.

Oocytes(eggsshownascircles)containingamixedpopulationofmutant(red)andnormal(green)mitochondriatransmitmtDNAafterfertilizationtodaughtercells.

Oocytemitochondrialreplacement

OurgoalToinvestigatethesafetyandeffectivenessofOocyteMitochondrialReplacement(OMR)asmeanstopreventtransmissionofmtDNAtooffspring.

Whatisinvolved?WomenwhocarrymtDNAmutationscanparticipateinthisstudy.TheywillundergotheeggharvestingstagesofInVitroFertilization(IVF),awell-establishedtreatmentformanyformsofinfertility.Thenucleargenomeofanunaffecteddonor’soocytewillberemoved.ThenthenuclearDNAfromtheoocytewithamtDNAmutationwillbetransferredintotheenucleatedoocyteofthedonor.Thisstudywillresultinembryosthatarecryopreservedandwillnotresultinpregnancy.Embryotransferintotheuterus(womb)maybepartofafuturestudythatwillrequireapprovalbytheFoodandDrugAdministration(FDA).

IRB-AAAM3550

for use until: 02/14/2018IRB Approval Date: 02/15/2017