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Completed

NCT Number: NCT01640067

Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)

Primary aim of the trial

1. to verify safety and tolerability of expanded human fetal neural stem cells 2. to verify safety and tolerability of a microsurgery human fetal neural stem cells transplantation model 3. to recognize each change in patient's quality of life

Secondary aim of the trial

1. assessment of the impact of human neural stem cells transplantation on the disability of ALS in a clinically significant and measurable way 2. Assessment of the impact of human neural stem cells transplantation on mortality (all causes)

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Azienda Ospedaliera Santa Maria

Terni, 05100, Italy

About this study

18 patients diagnosed as definite ALS according to the El Escorial criteria will be recruited during two years. The patients will be divided into 3 groups with different severity. Each group will be less compromised than the group that went before them. Their breathing measurements must be at least 60%. Subjects will receive injections of the human foetal neural stem cells into the spinal cord. A variety of tests and examinations will take place every month for the first year and every three months for the next two in order to monitor the course of the disease and the adverse events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of definite or possible ALS according to revised EL Escorial criteria
  • Age: 20-75 years
  • documented progression of disease during the last 6 months.
  • Absence of concomitant diseases
  • Adequate assurances of adherence to protocol
  • The patient must be able to communicate verbally or with the use of non-verbal communication system

Group 1

  • maximum score of 1 on walking item of ALS functional rating scale
  • forced vital capacity > or equal to 60

Group 2

  • forced vital capacity > or equal to 60
  • ambulation difficulties (maximum score of 2 on walking item of ALS functional rating scale)

Group 3

  • Independent ambulation (score 4 on a scale ALS-FRS)
  • forced vital capacity > or equal to 70

Exclusion criteria

The presence of at least one of the following will lead to patient exclusion.

  • psychiatric diseases or other neurological diseases different from ALS
  • other systemic diseases
  • Neoplasms or other diseases reducing life expectancy
  • Antecedent polio infection
  • corticosteroids, immunoglobulin or immunosuppressive treatment
  • involvement in other clinical trials
  • 2 or more critical items in MMPI
  • neuropsychological evaluation suggestive of mental deterioration or cognitive sphere disturbance.
  • Impediments to MRI
  • patients unable to understand informed consent form and study aims.
  • women who are pregnant or childbearing potential for the duration of the study. Non-pregnant status will be documented by beta-HCG negative test 7 days before treatment start

Treatment and study plan

Human Neural Stem Cells

Biological

Surgical microinjection of human neural stem cells on spinal cord of ALS patients

Other names: Human Neural Stem Cells Suspension

Primary outcomes

  1. safety of a microsurgery human neural stem cells transplantation into spinal cord of ALS patients

    Time frame: Participants will be followed for at least 3 years. Monthly in the first year and every three months the following two years

    • Percentage of subjects (%) with treatment-related mortality defined as death due to procedure and not to the course of the disease
    • Number of adverse events related to the procedure
    • Changes in neuroradiological (MRI) and neurophysiological variables (SEP, MEP)
    • Changes in neuropsychological variables

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Santa Maria, Terni, Italy

Other

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • University of Padova

Registry information

Official study title

Intra-spinal Cord Delivery of Human Neural Stem Cells in ALS Patients: Proposal for a Phase I Study/ Trapianto Intramidollare di Cellule Staminali Neurali Umane Come Terapia Putativa Per la SLA: Proposta di un Trial Clinico di Fase I

Acronym: hNSCALS

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jul 13, 2012
Registry last updated
Dec 30, 2015

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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