Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-02-18 @ 12:07 AM
Study NCT ID:
NCT04174157
Status:
RECRUITING
Last Update Posted:
2025-01-31
First Post:
2019-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710948', 'term': 'Zolgensma'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03955679', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2038-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-11-20', 'lastUpdatePostDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2038-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in probability of survival of all patients with SMA using Kaplan Meier method to estimate', 'timeFrame': 'Based on information collected at Baseline and every 6 months through 2 years of follow-up, then annually through 15 years of follow up.'}, {'measure': "Change from baseline Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) in infants with pre-symptomatic or type I SMA", 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up', 'description': 'CHOP INTEND score ranges from 0 to 64 with higher scores indicating higher motor function'}, {'measure': 'Change from baseline Hammersmith Infant Neurological Examination (HINE) in infants with pre-symptomatic, type I or type II SMA', 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up', 'description': 'HINE score range from 0 to 26 with higher scores indicating more development.'}, {'measure': 'Change from baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) for patients with type II and III SMA', 'timeFrame': 'Baseline and every 6months through 2 years of follow up, then annually through 15 years of follow up', 'description': 'HFMSE score range from 0 to 66 with the higher scores indicating more development.'}, {'measure': 'Incidence of treatment emergent adverse events', 'timeFrame': 'Through 15 years of follow up'}, {'measure': 'Incidence of treatment emergent serious adverse events', 'timeFrame': 'Through 15 years of follow up'}, {'measure': 'Incidence of treatment emergent adverse events related to therapy', 'timeFrame': 'Through 15 years of follow up'}, {'measure': 'Incidence of treatment emergent thrombocytopenia, hepatotoxicity and cardiac adverse events', 'timeFrame': 'Through 15 years of follow up'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in rates of hospitalization', 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up'}, {'measure': 'Change from baseline in Zarit Burden Interview', 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up', 'description': 'Zarit Burden Total Score ranges from 0 to 88. A higher score correlates with higher level of burden.'}, {'measure': 'Change from baseline in PedsQL Patient interview', 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up', 'description': 'PedsQL Total Scale Score is average of all items and ranges from 0 to 100. A higher score correlates with better Health-Related Quality of Life'}, {'measure': 'Change from baseline in PedsQL Parent interview', 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up', 'description': 'PedsQL Total Scale Score is average of all items and ranges from 0 to 100. A higher score correlates with better Health-Related Quality of Life'}, {'measure': 'Change from baseline in percent of patients requiring ventilator support (BiPAP, Endotracheal tube)', 'timeFrame': ': Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up'}, {'measure': 'Change from baseline in in percent of patients requiring nutritional support (Gastrostomy Tube, Gastrojejunal tube (GT) with Nissen fundoplication, GT without Nissen fundoplication, Nasogastrictube, Nasojejunaltube or Percutaneous endoscopic gastrostomy)', 'timeFrame': 'Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up'}, {'measure': 'Change from baseline in in percent of patients requiring mobility device support (Ankle-Foot Orthoses, Supramalleolar Orthosis, Orthotic/shoe inserts, Knee immobilizers, Knee-Ankle-Foot Orthoses , Hand splints, Spinal bracing)', 'timeFrame': ': Baseline and every 6 months through 2 years of follow up, then annually through 15 years of follow up'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Muscular Atrophy (SMA)']}, 'referencesModule': {'references': [{'pmid': '21811307', 'type': 'BACKGROUND', 'citation': 'Sugarman EA, Nagan N, Zhu H, Akmaev VR, Zhou Z, Rohlfs EM, Flynn K, Hendrickson BC, Scholl T, Sirko-Osadsa DA, Allitto BA. Pan-ethnic carrier screening and prenatal diagnosis for spinal muscular atrophy: clinical laboratory analysis of >72,400 specimens. Eur J Hum Genet. 2012 Jan;20(1):27-32. doi: 10.1038/ejhg.2011.134. Epub 2011 Aug 3.'}, {'pmid': '41217888', 'type': 'DERIVED', 'citation': 'Erbas Y, Servais L, Shieh PB, Goedeker NL, Waldrop MA, Bo R, Raju D, Benguerba K, Reyna SP, Wolff D, Finkel RS. Trach and treat: Safety and motor outcomes following onasemnogene abeparvovec in patients with spinal muscular atrophy and tracheostomies in the RESTORE registry. J Neuromuscul Dis. 2025 Nov 11:22143602251395173. doi: 10.1177/22143602251395173. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Spinal muscular atrophy (SMA) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (SMN1) on chromosome 5q13, which leads to reduced SMN protein levels and a selective dysfunction of motor neurons. SMA is an autosomal recessive, early childhood disease with an incidence of 1:10,000 live births. SMA is the leading cause of infant mortality due to genetic diseases.\n\nThe purpose of this registry is to assess the long term outcomes of patients with SMA in the context of advances in treatment options and also to characterize and assess long-term safety and effectiveness of OAV-101.', 'detailedDescription': "This is a prospective, multi center, multinational, non-interventional observational study. All patients will be managed according to the clinical site's normal clinical practice, i.e., the diagnostic and clinical treatment/practice process that a clinician chooses according to their clinical judgement for an SMA patient. Clinical care will not be driven by the protocol. No additional visits or investigations will be performed beyond normal clinical practice. Patients will be followed for 15 years from enrolment or until death, whichever is sooner."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll at least 500 patients with a genetically confirmed diagnosis of SMA. The registry will attempt to enroll all patients treated with OAV-101 in the registry until the end of 2026.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated with OAV-101 with a genetically confirmed diagnosis of SMA regardless of the date of diagnosis.\n* Appropriate consent/assent has been obtained for participation in the registry\n\nExclusion Criteria:\n\n\\- Currently enrolled in an interventional clinical trial involving an investigational medicinal product to treat SMA.\n\nNote: Patients who are participating in a Compassionate Use Program (CUP) for OAV-101 (Zolgensma) such as a Managed Access Program (MAP), an Expanded Access Program (EAP), Single Patient Investigational New Drug (IND) (SPI) or Named Patient Program (NPP) are eligible to enroll in the registry regardless of the date of a genetic or clinical diagnosis of SMA.'}, 'identificationModule': {'nctId': 'NCT04174157', 'briefTitle': 'Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Long-Term Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)', 'orgStudyIdInfo': {'id': 'COAV101A12001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective observational registry', 'description': 'This is a prospective, multi center, multinational, non-interventional observational registry.', 'interventionNames': ['Other: Prospective observational registry', 'Drug: Zolgensma']}], 'interventions': [{'name': 'Prospective observational registry', 'type': 'OTHER', 'description': 'This prospective observational registry will assess long-term outcomes of patients with a diagnosis of SMA.', 'armGroupLabels': ['Prospective observational registry']}, {'name': 'Zolgensma', 'type': 'DRUG', 'description': 'Zolgensma will be given to patients as per normal clinical practice and clinical care will not be mandated by the protocol. As such, the decision to prescribe Zolgensma is separate from the decision to include the patient in this study', 'armGroupLabels': ['Prospective observational registry']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alison Lane', 'role': 'CONTACT', 'email': 'alane@phoenixchildrens.com', 'phone': '602-933-0885'}, {'name': 'Saunder Bernes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kapil Arya', 'role': 'CONTACT', 'email': 'karya@uams.edu', 'phone': '501-364-1850'}, {'name': 'Kapil Arya, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92350', 'city': 'Loma Linda', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Loma Linda University Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Martha Arellano-Garcia', 'role': 'CONTACT', 'email': 'margarcia@chla.usc.edu', 'phone': '323-361-5812'}, {'name': 'Claudia Dozal', 'role': 'CONTACT', 'email': 'cdozal@chla.usc.edu', 'phone': '(323) 361-5825'}, {'name': 'Leigh Maria Ramos-Platt, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Huynh Jennifer', 'role': 'CONTACT', 'email': 'JenniferH@mednet.ucla.edu', 'phone': '310-825-3564'}, {'name': 'Perry Shieh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Los Angeles Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raymund David, MD', 'role': 'CONTACT', 'email': 'RDavid@valleychildrens.org', 'phone': '559-353-6215'}, {'name': 'Raymund David, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Valley Children's Healthcare", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '93638', 'city': 'Madera', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amanda Fernandez, MD', 'role': 'CONTACT', 'email': 'afernandez@choc.org', 'phone': '559-353-6215'}, {'name': 'Linda Do', 'role': 'CONTACT', 'email': 'Linh.Do@choc.org', 'phone': '(714) 696-2665'}, {'name': 'Amanda Fernandez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel (Ja Yoon) Baek', 'role': 'CONTACT', 'email': 'jrbaek@ucdavis.edu', 'phone': '916-734-2439'}, {'name': 'Nanette Joyce, DO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis Health System', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chamindra Konersman, MD', 'role': 'CONTACT', 'email': 'ckonersman@health.ucsd.edu', 'phone': '858-966-5819'}, {'name': 'Napat Intarachumnum', 'role': 'CONTACT', 'email': 'nintarachumnum@health.ucsd.edu', 'phone': '858-576-1700'}, {'name': 'Chamindra Konersman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Rady Children's Hospital San Diego", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Margaret Finlay', 'role': 'CONTACT', 'email': 'margaret.finlay@childrenscolorado.org', 'phone': '720-777-1234'}, {'name': 'Julie Parsons, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06034', 'city': 'Farmington', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hendriana Nielsen', 'role': 'CONTACT', 'email': 'HNielsen@connecticutchildrens.org', 'phone': '860-837-5881'}, {'name': 'James Santanelli', 'role': 'CONTACT', 'email': 'jsantanelli@connecticutchidlrens.org', 'phone': '(860) 837-5873'}, {'name': 'Gyula Acsadi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine Tsao', 'role': 'CONTACT', 'email': 'catherine.tsao@yale.edu', 'phone': '203-785-4390'}, {'name': 'Cristian Ionita, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale-New Haven Health System', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33908', 'city': 'Fort Myers', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Britt Stroud, MD', 'role': 'CONTACT', 'email': 'britt.stroud@leehealth.org', 'phone': '239-343-5437'}, {'name': 'Molly Arnstrom', 'role': 'CONTACT', 'email': 'Molly.arnstrom@leehealth.org', 'phone': '(239) 343-5437'}, {'name': 'Britt Stroud, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Golisano Children's Hospital of Southwest Florida", 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Adventist Health System - Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33157', 'city': 'Palmetto Bay', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paula Schleifer, MD', 'role': 'CONTACT', 'email': 'pschleifer@fcneurology.net', 'phone': '305-279-2226'}, {'name': 'Paula Schleifer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jackson South Medical Center', 'geoPoint': {'lat': 25.62177, 'lon': -80.32477}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marcia Felker, MD', 'role': 'CONTACT', 'email': 'mamccann@iupui.edu', 'phone': '317-948-7450'}, {'name': 'Leanne Dunn', 'role': 'CONTACT', 'email': 'lkhernan@iu.edu', 'phone': '317-278-7815'}, {'name': 'Marcia Felker, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University Health University Hospital (IUHUH)', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chandra Miller', 'role': 'CONTACT', 'email': 'Chandra-miller@uiowa.edu', 'phone': '319-384-9618'}, {'name': 'Carrie Stephan', 'role': 'CONTACT', 'email': 'Carrie-stephan@uiowa.edu', 'phone': '(319) 356-2673'}, {'name': 'Katherine Mathews, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Clay', 'role': 'CONTACT', 'email': 'rclay@kumc.edu', 'phone': '913-588-1227'}, {'name': 'Jeffrey Statland, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Evanczyk', 'role': 'CONTACT', 'email': 'Lauren.evanczyk@nortonhealthcare.org', 'phone': '502-588-3650'}, {'name': 'Arpita Lakhotia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seth Stafki, MD', 'role': 'CONTACT', 'email': 'stafk006@umn.edu', 'phone': '218-298-2747'}, {'name': 'Peter Karachunski, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Bonnett', 'role': 'CONTACT', 'email': 'bonnetta@health.missouri.edu', 'phone': '573-884-6119'}, {'name': 'Jane Emerson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Missouri Health System', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalie Goedeker', 'role': 'CONTACT', 'email': 'ngoedeker@wustl.edu', 'phone': '314-362-4919'}, {'name': 'Craig Zaidman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Darius Adams, MD', 'role': 'CONTACT', 'email': 'adamsd@mail.amc.edu', 'phone': '518-262-5120'}, {'name': 'Darius Adams, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Atlantic Health System', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Bohoon Lee', 'role': 'CONTACT', 'email': 'Bohoon_Lee@URMC.Rochester.edu', 'phone': '585-275-2776'}, {'name': 'Kim Hart Kim_', 'role': 'CONTACT', 'email': 'Hart@URMC.Rochester.edu'}, {'name': 'Bohoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Christine Pol', 'role': 'CONTACT', 'email': 'Christiana.Pol@stonybrookmedicine.edu', 'phone': '631-444-9083'}, {'name': 'Simona Treidler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The State University of New York', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karen Cornett', 'role': 'CONTACT', 'email': 'k.cornett@duke.edu', 'phone': '919-684-1143'}, {'name': 'Mai Elmallah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke Health', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44308-1062', 'city': 'Akron', 'state': 'Ohio', 'status': 'COMPLETED', 'country': 'United States', 'facility': "Akron Children's Hospital", 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '45229-3026', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Hunsaker', 'role': 'CONTACT', 'email': 'emily.hunsaker@cchmc.org', 'phone': '513-636-5511'}, {'name': 'Cuixia Tian, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 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'email': 'McCarbry@ohsu.edu', 'phone': '503-418-8297'}, {'name': 'Erika Finanger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Stoute', 'role': 'CONTACT', 'email': 'estoute@pennstatehealth.psu.edu', 'phone': '717-531-1260'}, {'name': 'Ashutosh Kumar, MD', 'role': 'CONTACT', 'email': 'akumar5@pennstatehealth.psu.edu', 'phone': '(717) 531-8790'}], 'facility': 'Penn State Hershey', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emma Sekscinski', 'role': 'CONTACT', 'email': 'ecs112@pitt.edu', 'phone': '302-393-6102'}, {'name': 'Hoda Abdel-Hamid, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of 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the International Committee of Medical Journal Editors (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals (www.icmje.org).\n\nThe physician agrees that if the physician is part of a multi-center registry, the physician shall coordinate in advance any intended disclosure of the results of the registry with Novartis Gene Therapies to ensure that the results of individual physicians are not published or presented before those of the multi-center registry, unless otherwise agreed to in writing by Novartis Gene Therapies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}