Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1

PHASE3CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

November 12, 2019

Study Completion Date

November 12, 2019

Conditions
SMA - Spinal Muscular AtrophyGene Therapy
Interventions
BIOLOGICAL

Onasemnogene Abeparvovec-xioi

Non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription.

Trial Locations (16)

10032

Columbia University, New York

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins Pediatric Neurology, Baltimore

27713

Duke University, Durham

32827

Nemours Children's Hospital, Orlando

43205

Nationwide Children's Hospital, Columbus

53792

University of Wisconsin (Madison), Madison

60611

Ann and Robert H Lurie Children's Hospital, Chicago

63110

Washington Unviersity School of Medicine, St Louis

75235

University of Texas Southwestern Medical Center, Dallas

80045

Children's Hospital Colorado, Aurora

84112

University of Utah, Salt Lake City

90095

David Geffen School of Medicine at UCLA, Los Angeles

94305

Stanford University, Stanford

97239

Oregon Health and Science University, Portland

02115

Boston Children's Hospital, Boston

Sponsors
All Listed Sponsors
lead

Novartis Gene Therapies

INDUSTRY

NCT03306277 - Gene Replacement Therapy Clinical Trial for Participants With Spinal Muscular Atrophy Type 1 | Biotech Hunter | Biotech Hunter