Metabolomics Workbench : NIH Data Repository

MB Sample ID: SA308943

Local Sample ID:	DS1-123-004
Subject ID:	SU002970
Subject Type:	Human
Subject Species:	Homo sapiens
Taxonomy ID:	9606
Gender:	Male and female

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Treatment:

Treatment ID:	TR002979
Treatment Summary:	A total of 180 candidates volunteered between September 26, 2017, and January 13, 2020. The study was conducted in three centers. Two Italian centers, the ‘IRCCS Casa Sollievo della Sofferenza’ Research Hospital (Site 1) and the ‘Santa Maria di Terni’ Hospital (Site 2) recruited patients and performed the MRI examinations. The Multiple Sclerosis Centre of the Neurocentre of Southern Switzerland (Site 3) performed the magnetic resonance imaging (MRI) analysis. The ICVI of the ACT was performed at Site 2. Screening was done one month prior to enrolment in the study. The run-in period started after the screening examination (Run-in-START) and lasted three months (Run-in-END). After screening in the two recruiting centers (as above), n= 15 subjects with active and non-active SPMS suffering from progressive disability were found to be eligible, consented, and were assigned a unique identification number. Participants, nine females and six males, had a mean age of 50 years (range: 38–57), and were recruited in similar proportions by the two study sites. The mean EDSS was 7.6 (range 7–8), mean disease duration was 23 years (range 14–30), and mean time from diagnosis to secondary progression was 10 years (range: 1–20). The hNSC-SPMS study was advertised using the website of the hospitals and social media (eg Facebook and Twitter). The first patient selection was performed based on the documentation provided. Selected patients were then summoned in Site 1 and Site 2 (as above) for a first pre-screening meeting with the clinicians. Patients who agreed to participate were then subjected to the screening visit for the clinical trial. Following the surgical procedure, follow-up visits were performed monthly up to 12 months. Before transplantation, all patients underwent the following examinations (at both Run-in-START and Run-in-END): physical and neurological exams; vital signs; pregnancy tests (in fertile women); haematological and urine tests; lumbar puncture for serum and CSF collection (stored at -80°C);

Treatment ID:

TR002979

Treatment Summary:

A total of 180 candidates volunteered between September 26, 2017, and January 13, 2020. The study was conducted in three centers. Two Italian centers, the ‘IRCCS Casa Sollievo della Sofferenza’ Research Hospital (Site 1) and the ‘Santa Maria di Terni’ Hospital (Site 2) recruited patients and performed the MRI examinations. The Multiple Sclerosis Centre of the Neurocentre of Southern Switzerland (Site 3) performed the magnetic resonance imaging (MRI) analysis. The ICVI of the ACT was performed at Site 2. Screening was done one month prior to enrolment in the study. The run-in period started after the screening examination (Run-in-START) and lasted three months (Run-in-END). After screening in the two recruiting centers (as above), n= 15 subjects with active and non-active SPMS suffering from progressive disability were found to be eligible, consented, and were assigned a unique identification number. Participants, nine females and six males, had a mean age of 50 years (range: 38–57), and were recruited in similar proportions by the two study sites. The mean EDSS was 7.6 (range 7–8), mean disease duration was 23 years (range 14–30), and mean time from diagnosis to secondary progression was 10 years (range: 1–20). The hNSC-SPMS study was advertised using the website of the hospitals and social media (eg Facebook and Twitter). The first patient selection was performed based on the documentation provided. Selected patients were then summoned in Site 1 and Site 2 (as above) for a first pre-screening meeting with the clinicians. Patients who agreed to participate were then subjected to the screening visit for the clinical trial. Following the surgical procedure, follow-up visits were performed monthly up to 12 months. Before transplantation, all patients underwent the following examinations (at both Run-in-START and Run-in-END): physical and neurological exams; vital signs; pregnancy tests (in fertile women); haematological and urine tests; lumbar puncture for serum and CSF collection (stored at -80°C);