Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01640067
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : December 30, 2015
Sponsor:
Collaborators:
Azienda Ospedaliero Universitaria Maggiore della Carita
Università di Padova Italy
Information provided by (Responsible Party):
Angelo Luigi Vescovi, Azienda Ospedaliera Santa Maria, Terni, Italy

Tracking Information
First Submitted Date  ICMJE July 9, 2012
First Posted Date  ICMJE July 13, 2012
Last Update Posted Date December 30, 2015
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01640067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE 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
Brief Summary

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)
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Biological: Human Neural Stem Cells
Surgical microinjection of human neural stem cells on spinal cord of ALS patients
Other Name: Human Neural Stem Cells Suspension
Study Arms  ICMJE Experimental: Human Neural Stem Cells Suspension
50,000 cells/µl. Patients received either unilateral or bilateral hNSCs microinjections (3 microinjections on each side) into the lumbar spinal cord. Each microinjection consisted of 15 µl of the above 50,000cells/µl suspension, yielding a total of 750,000 cells per injection site.
Intervention: Biological: Human Neural Stem Cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2012)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

  1. psychiatric diseases or other neurological diseases different from ALS
  2. other systemic diseases
  3. Neoplasms or other diseases reducing life expectancy
  4. Antecedent polio infection
  5. corticosteroids, immunoglobulin or immunosuppressive treatment
  6. involvement in other clinical trials
  7. 2 or more critical items in MMPI
  8. neuropsychological evaluation suggestive of mental deterioration or cognitive sphere disturbance.
  9. Impediments to MRI
  10. patients unable to understand informed consent form and study aims.
  11. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01640067
Other Study ID Numbers  ICMJE EudraCT: 2009-014484-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Angelo Luigi Vescovi, Azienda Ospedaliera Santa Maria, Terni, Italy
Study Sponsor  ICMJE Azienda Ospedaliera Santa Maria, Terni, Italy
Collaborators  ICMJE
  • Azienda Ospedaliero Universitaria Maggiore della Carita
  • Università di Padova Italy
Investigators  ICMJE
Principal Investigator: Angelo L Vescovi, Professor IRCCS Casa Sollievo della Soffernza and AOSP Terni, Italy
PRS Account Azienda Ospedaliera Santa Maria, Terni, Italy
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP