Summary of Study ST002858

This data is available at the NIH Common Fund's National Metabolomics Data Repository (NMDR) website, the Metabolomics Workbench, https://www.metabolomicsworkbench.org, where it has been assigned Project ID PR001789. The data can be accessed directly via it's Project DOI: 10.21228/M8G43R This work is supported by NIH grant, U2C- DK119886.

See: https://www.metabolomicsworkbench.org/about/howtocite.php

This study contains a large results data set and is not available in the mwTab file. It is only available for download via FTP as data file(s) here.

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Study IDST002858
Study TitleIntracerebroventricular Transplantation of Foetal Allogeneic Neural Stem Cells in Patients with Secondary Progressive Multiple Sclerosis (hNSC-SPMS): a phase I dose-escalation clinical trial - Metabolomics Analysis of Human Serum
Study SummaryThis is an open-label, first-in-human, dose-escalation phase I study (NCT03282760, EudraCT2015‐004855‐37) to determine the feasibility, safety, and tolerability of the transplantation of allogeneic human neural stem/progenitor cells (hNSCs) for the treatment of progressive multiple sclerosis. We report the analysis of 1 year of data from the first cohort of 15 patients from two trial sites that received increasing numbers of allogeneic hNSCs delivered via intracerebroventricular injection in combination with an immunosuppressive regimen. No treatment-related deaths nor serious adverse events (AEs) were observed over the 12-month follow-up. Participants displayed stability of clinical and laboratory parameters, as well as lesion load and activity at the brain MRIs, compared to study entry. Longitudinal metabolomics and lipidomics analyses of cerebrospinal fluid and serum from these patients identified time and dose-dependent responses, with increased levels of free fatty acids and acylcarnitines in the CSF, especially at the highest dose of injected hNSCs at the one-year follow-up time point. Finally, a significant inverse correlation was found between the highest dose of injected hNSCs and the smaller parenchymal brain volume change (PBVC; Spearman’s rho= -0.7, p= 0.03), clinical covariates that correlated with CSF levels of free fatty acids, acyl-carnitines, oxylipins, conjugated bile acids and purine breakdown and deamination products, such as hypoxanthine. The absence of AEs and the stability of functional and structural outcomes is reassuring in terms of risks and represent a main milestone to rigorously address the challenges for the safe translation of key principles of stem cell biology into effective regenerative medicines.
Institute
University of Colorado Anschutz Medical Campus
Last NameStephenson
First NameDaniel
AddressResearch 1 South L18-1303 12801 E. 17th Ave., Aurora, Colorado, 80045, USA
Emaildaniel.stephenson@cuanschutz.edu
Phone303-724-3339
Submit Date2023-09-11
Raw Data AvailableYes
Raw Data File Type(s)mzXML
Analysis Type DetailGC/LC-MS
Release Date2023-09-27
Release Version1
Daniel Stephenson Daniel Stephenson
https://dx.doi.org/10.21228/M8G43R
ftp://www.metabolomicsworkbench.org/Studies/ application/zip

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Factors:

Subject type: Human; Subject species: Homo sapiens (Factor headings shown in green)

mb_sample_id local_sample_id TIMEPOINT
SA308864DS1-123-135FU1
SA308865DS1-123-091FU1
SA308866DS1-123-140FU1
SA308867DS1-123-034FU1
SA308868DS1-123-104FU1
SA308869DS1-123-047FU1
SA308870DS1-123-098FU1
SA308871DS1-123-056FU1
SA308872DS1-123-054FU1
SA308873DS1-123-023FU1
SA308874DS1-123-069FU1
SA308875DS1-123-075FU1
SA308876DS1-123-006FU1
SA308877DS1-123-147FU1
SA308878DS1-123-009FU1
SA308879DS1-123-113FU12
SA308880DS1-123-090FU12
SA308881DS1-123-048FU12
SA308882DS1-123-045FU12
SA308883DS1-123-086FU12
SA308884DS1-123-137FU12
SA308885DS1-123-149FU12
SA308886DS1-123-064FU12
SA308887DS1-123-026FU12
SA308888DS1-123-059FU12
SA308889DS1-123-030FU12
SA308890DS1-123-088FU3
SA308891DS1-123-129FU3
SA308892DS1-123-152FU3
SA308893DS1-123-153FU3
SA308894DS1-123-155FU3
SA308895DS1-123-150FU3
SA308896DS1-123-143FU3
SA308897DS1-123-096FU3
SA308898DS1-123-119FU3
SA308899DS1-123-138FU3
SA308900DS1-123-092FU3
SA308901DS1-123-078FU3
SA308902DS1-123-012FU3
SA308903DS1-123-061FU3
SA308904DS1-123-053FU3
SA308905DS1-123-033FU6
SA308906DS1-123-084FU6
SA308907DS1-123-121FU6
SA308908DS1-123-128FU6
SA308909DS1-123-108FU6
SA308910DS1-123-036FU6
SA308911DS1-123-044FU6
SA308912DS1-123-065FU6
SA308913DS1-123-068FU6
SA308914DS1-123-017FU6
SA308915DS1-123-010FU6
SA308916DS1-123-120FU9
SA308917DS1-123-020FU9
SA308918DS1-123-156FU9
SA308919DS1-123-154FU9
SA308920DS1-123-151FU9
SA308921DS1-123-126FU9
SA308922DS1-123-112FU9
SA308923DS1-123-055FU9
SA308924DS1-123-060FU9
SA308925DS1-123-062FU9
SA308926DS1-123-095FU9
SA308927DS1-123-066FU9
SA308928DS1-123-022REND
SA308929DS1-123-029REND
SA308930DS1-123-041REND
SA308931DS1-123-079REND
SA308932DS1-123-019REND
SA308933DS1-123-077REND
SA308934DS1-123-008REND
SA308935DS1-123-144REND
SA308936DS1-123-074REND
SA308937DS1-123-132REND
SA308938DS1-123-110REND
SA308939DS1-123-122REND
SA308940DS1-123-097REND
SA308941DS1-123-049REND
SA308942DS1-123-101REND
SA308943DS1-123-004START
SA308944DS1-123-013START
SA308945DS1-123-040START
SA308946DS1-123-016START
SA308947DS1-123-107START
SA308948DS1-123-067START
SA308949DS1-123-038START
SA308950DS1-123-052START
SA308951DS1-123-089START
SA308952DS1-123-082START
SA308953DS1-123-024START
SA308954DS1-123-118START
SA308955DS1-123-115START
SA308956DS1-123-141START
SA308957DS1-123-002START
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