Safety Study of Human Neural Stem Cells Injections for Secondary Progr
A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Human Neural Stem Cells
What it measured
Main measures
Incidence of Treatment Emergent AE
1 year
SafetyFeasibilityPercentage of Mortality in treated patients
1 year
Other measures (5)
Change in Functional disability
Up to 1 year
Disability progressionBladder, bowel and sexual functionThinking and memoryArm and hand functionActivity of Cognitive function
Up to 1 year
Thinking and memoryRelapses Rate
Up to 1 year
Disability progressionRelapsesMS Biomarkers
Up to 1 year
Blood or spinal fluid markersAlteration in Neurophysiological parameters
Up to 1 year
Myelin repairNerve conduction tests
Who could take part
Progressive MS · 18 to 60
Show the full criteria
Inclusion criteria
1. SPMS with progressive accumulation of disability after initial relapsing course, with or without disease activity (Lublin et al. 2014). 2. EDSS ≥ 6.5 and ≤ 8 3. EDSS progression over the 2 years prior to study start of ≥ 1.0 point for patients with EDSS =6.5 at the time of inclusion , and of ≥ 0.5 points for patients with EDSS > 6.5 at the time of inclusion 4. Age ≥ 18 and ≤ 60 years 5. Failure of best medical treatment as judged by the treating neurologist and declared absence of therapeutic alternatives
Exclusion criteria
1. Neurological conditions other than MS. 2. Psychiatric disorders, severe cognitive decline and personality and relational disorders. 3. History or known presence of significant systemic, infectious, oncologic or metabolic disorders. 4. Presence of any other autoimmune disease. 5. Chronic infections (HBV, HCV, HIV, tuberculosis). 6. Inability to perform MRI scans. 7. Immunomodulant/immunosuppressive treatments in the last 6 months before inclusion. 8. Current participation to other experimental studies. 9. Inability to provide informed consent. 10. Any contra-indication to lumbar puncture and the surgical procedure (e.g. use of anticoagulants) 11. Pregnancy and breast feeding.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This will be a phase I, open, multicenter, international study performed by 3 participating centres across two countries (Italy and Switzerland). Fifteen to 24 patients affected by SPMS will be enrolled, according to a "standard" phase I design over 18 months. All patients will enter a 3 months run in phase. Thereafter they will receive one of four different doses of allogenic hNSCs (dose A=5 millions hNSCs; dose B=10 millions hNSCs; dose C=16 millions hNSCs; dose D=24 millions hNSCs). Following hNSCs injection, all SPMS patients will receive immunosuppression with tacrolimus for 6 months. Patients will be clinically followed monthly for 1 year and then every 6 months for the 5 years following the study completion (possibly all life long). MRI assessments will be performed monthly for the first 6 months and then every 3 months for 5 years following the study completion.
Papers
Results
Phase I clinical trial of intracerebroventricular transplantation of allogeneic neural stem cells in people with progressive multiple sclerosis.Cell Stem Cell · 2023
Results
Results from Phase I Clinical Trial with Intraspinal Injection of Neural Stem Cells in Amyotrophic Lateral Sclerosis: A Long-Term Outcome.Stem Cells Transl Med · 2019
Results
Gelati M, Profico DC, Ferrari D, Vescovi AL. Culturing and Expansion of "Clinical Grade" Neural Stem Cells from the Fetal Human Central Nervous System. Methods Mol Biol. 2022;2389:57-66. doi: 10.1007/978-1-0716-1783-0_5.Background
Gelati M, Profico D, Projetti-Pensi M, Muzi G, Sgaravizzi G, Vescovi AL. Culturing and expansion of "clinical grade" precursors cells from the fetal human central nervous system. Methods Mol Biol. 2013;1059:65-77. doi: 10.1007/978-1-62703-574-3_6.Background
Mazzini L, Gelati M, Profico DC, Sgaravizzi G, Projetti Pensi M, Muzi G, Ricciolini C, Rota Nodari L, Carletti S, Giorgi C, Spera C, Domenico F, Bersano E, Petruzzelli F, Cisari C, Maglione A, Sarnelli MF, Stecco A, Querin G, Masiero S, Cantello R, Ferrari D, Zalfa C, Binda E, Visioli A, Trombetta D, Novelli A, Torres B, Bernardini L, Carriero A, Prandi P, Servo S, Cerino A, Cima V, Gaiani A, NasuBackground
Pluchino S, Gritti A, Blezer E, Amadio S, Brambilla E, Borsellino G, Cossetti C, Del Carro U, Comi G, 't Hart B, Vescovi A, Martino G. Human neural stem cells ameliorate autoimmune encephalomyelitis in non-human primates. Ann Neurol. 2009 Sep;66(3):343-54. doi: 10.1002/ana.21745.Background
Pluchino S, Quattrini A, Brambilla E, Gritti A, Salani G, Dina G, Galli R, Del Carro U, Amadio S, Bergami A, Furlan R, Comi G, Vescovi AL, Martino G. Injection of adult neurospheres induces recovery in a chronic model of multiple sclerosis. Nature. 2003 Apr 17;422(6933):688-94. doi: 10.1038/nature01552.Background
Ferrari D, Zalfa C, Nodari LR, Gelati M, Carlessi L, Delia D, Vescovi AL, De Filippis L. Differential pathotropism of non-immortalized and immortalized human neural stem cell lines in a focal demyelination model. Cell Mol Life Sci. 2012 Apr;69(7):1193-210. doi: 10.1007/s00018-011-0873-5. Epub 2011 Nov 11.
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History
Started
Sept 2017
Main results due
May 2021
Finished
May 2021