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Completed

NCT Number: NCT03282760

Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients

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.

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Key information

Conditions

Secondary-progressive Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Casa Sollievo della Sofferenza - IRCCS, San Giovanni Rotondo, Foggia, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SPMS with progressive accumulation of disability after initial relapsing course, with or without disease activity (Lublin et al. 2014).
  • EDSS ≥ 6.5 and ≤ 8
  • 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
  • Age ≥ 18 and ≤ 60 years
  • Failure of best medical treatment as judged by the treating neurologist and declared absence of therapeutic alternatives

Exclusion criteria

  • Neurological conditions other than MS.
  • Psychiatric disorders, severe cognitive decline and personality and relational disorders.
  • History or known presence of significant systemic, infectious, oncologic or metabolic disorders.
  • Presence of any other autoimmune disease.
  • Chronic infections (HBV, HCV, HIV, tuberculosis).
  • Inability to perform MRI scans.
  • Immunomodulant/immunosuppressive treatments in the last 6 months before inclusion.
  • Current participation to other experimental studies.
  • Inability to provide informed consent.
  • Any contra-indication to lumbar puncture and the surgical procedure (e.g. use of anticoagulants)
  • Pregnancy and breast feeding.

Treatment and study plan

Human Neural Stem Cells

Biological

Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10, 16 or 24 millions). hNSCs are produced by the Laboratorio Cellule Staminali of Terni according to GMP guidelines and are obtained from brain specimens of several fetal human donors from spontaneous miscarriages occurred after the 8th week after conception.

Primary outcomes

  1. Incidence of Treatment Emergent AE

    Time frame: 1 year

    To Evaluate the Feasibility, Safety and Tolerability of intracerebroventricular injection of allogenic hNSCs

  2. Percentage of Mortality in treated patients

    Time frame: 1 year

    Percentage of subjects (%) with death due to procedure (mortality correlated to treatment)

Secondary outcomes

  1. Change in Functional disability

    Time frame: Up to 1 year

    this will be measured by the change of the Expanded Disability Scale (EDSS-disability score about pyramidal, cereberral, brainstem, sensory, bowel and bladder, visual, cerebral Functional Systems) during the study period.

  2. Change in Functional disability

    Time frame: Up to 1 year

    this will be measured by the change of the the Multiple Sclerosis Functional Composite (MSFC-scores about upper extremity function, ambulation and cognitive function) during the study period.

  3. Activity of Cognitive function

    Time frame: Up to 1 year

    This will be measured as the mean change of the score of the RAO Brief Repeatable Battery of Neuropsychological Test, during the study period.

  4. Relapses Rate

    Time frame: Up to 1 year

    Relapses will be measured by the change in EDSS scale

  5. Relapses Rate

    Time frame: Up to 1 year

    Relapses will be measured by the Imaging evaluations

  6. MS Biomarkers

    Time frame: Up to 1 year

    Investigation of potential candidate biomarkers able to monitor disease activity and predict clinical course in MS (Neurofilaments)

  7. Alteration in Neurophysiological parameters

    Time frame: Up to 1 year

    Assessed by Evoked Potentials.

Sponsors and collaborators

Lead sponsor

Casa Sollievo della Sofferenza IRCCS

Other

Collaborators

  • Associazione Revert ONLUS
  • Fondazione Cellule Staminali
  • Neurocenter of Southern Switzerland

Registry information

Official study title

A Phase I Multicenter Study of Allogenic, Intracerebroventricular Human Neural Stem Cells Transplantation for the Experimental Treatment of Secondary Progressive Multiple Sclerosis Patients

Acronym: NSC-SPMS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Sep 14, 2017
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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