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

NCT01640067 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2015-12-30

No results posted yet for this study

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)

Conditions

Interventions

BIOLOGICAL

Human Neural Stem Cells

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

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    collaborator OTHER

  • Università di Padova Italy

    collaborator UNKNOWN

  • Azienda Ospedaliera Santa Maria, Terni, Italy

    lead OTHER

Principal Investigators

  • Angelo L Vescovi, Professor · IRCCS Casa Sollievo della Soffernza and AOSP Terni, Italy

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640067 on ClinicalTrials.gov