Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI

Sponsor
Neuralstem Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT01772810
Collaborator
(none)
8
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Study Details

Study Description

Brief Summary

This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.

Condition or Disease Intervention/Treatment Phase
  • Drug: Human spinal cord stem cells.
Phase 1

Detailed Description

Phase I, open-label, single-site, safety study of HSSC transplantation for the treatment of chronic spinal cord injury (SCI). Group A enrolled 4 subjects with a cord injury at T2-T12; Group B will enroll 4 subjects with a C5-C7 cord injury. Study period will be 6 months post-operative. Post-study, subjects will be followed for an additional 54 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Single-site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI
Actual Study Start Date :
Aug 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2018
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Surgical implantation of human spinal cord stem cells

Surgical implantation of human spinal cord derived neural stem cells.

Drug: Human spinal cord stem cells.
Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.
Other Names:
  • spinal cord injury (SCI)
  • Outcome Measures

    Primary Outcome Measures

    1. Adverse events and clinically significant laboratory abnormalities [6 months]

    Secondary Outcome Measures

    1. Graft survival in the transplant site as determined by MRI (for Group A) and via autopsy, if one is completed. [Month 60]

      Effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.

    Other Outcome Measures

    1. EMG, SCIM, ISNC SCI, and Bowel and bladder follow-up [60 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Lives within 500 miles of study center (For Group B)
    1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures

    2. Men and women 18-65 years old

    3. Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy or oophorectomy or surgical sterilization)

    4. At least 1 year but no more than 2 years from time of injury at the time of surgery

    5. SCI injury classified as AIS-A complete as confirmed by the PI and a Physical Medicine and Rehabilitation doctor or other SCI Medicine board certified physician based on a complete ISNC SCI examination

    6. Neurologic level of injury:

    7. Group A: injury within cord segments T2-T12;

    8. Group B: injury within cord segments C5-C7

    9. Confirmation of bone fusion by CT scan

    10. Agrees to the visit schedule as outlined in the informed consent

    11. All required vaccinations current at the time of enrollment: tetanus/diptheria (TDAP), herpes zoster/shingles (Zostavax®: within last 10 years and must be prior to surgery), pneumonia (Pneumovax®), seasonal/H1N1 flu vaccines (as appropriate for season). Any missing vaccination will be provided at the screening if consented by the otherwise eligible patient who will then be scheduled for surgery no less than 30 days post vaccination.

    Exclusion Criteria:
    1. SCI due to penetrating trauma such as gun shot or stabbing wound

    2. SCI injuries involving complete spinal cord transection

    3. Etiology of paraplegia or weakness related to other or additional neurologic process

    4. MRI evidence of syrinx, multiple cysts, or a cyst with greater than 2cm in length or injury site involving greater than 2cm of the cord

    5. Current or peak Panel Reactive Antibody (PRA) due to alloantibodies > 20% receiving their first allograft or presence of antibodies against HLA of the donor cells

    6. Receipt of any investigational drug or device within 30 days prior to surgery

    7. Receipt of any cell infusion other than blood transfusion

    8. Any concomitant medical disease or condition noted below:

    9. Coagulopathy with INR > 1.4 at the time of screening

    10. Active infection

    11. Active hypotension requiring vasopressor therapy

    12. Skin breakdown over the site of surgery

    13. History of Malignancy (except for non-melanoma skin cancer)

    14. Primary or secondary immune deficiency

    15. Persistent MRI artifact that would prevent imaging post-op h. Creatinine >1.5, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) > 2x upper limit of normal, hematocrit/hemoglobin < 30/10, total WBC < 3000, uncontrolled hypertension (systolic > 180 or diastolic > 100) or uncontrolled diabetes (defined as hemoglobin A1C >8), evidence of GI bleeding by hemoccult test, positive tuberculosis, hepatitis B or C, or human immunodeficiency virus (HIV)

    16. Presence of any of the following conditions:

    17. Current drug abuse or alcoholism

    18. Unstable medical conditions

    19. Unstable psychiatric illness including psychosis and untreated major depression

    20. Any condition that the Investigator or primary physician feels may interfere with participation in the study

    21. Any condition that the surgeon feels may pose complications for the surgery

    22. Known hypersensitivity to basiliximab, tacrolimus or mycophenolate mofetil

    23. Inability to provide informed consent as determined by screening protocol.

    24. Stage III or above decubitus wound, other open wound, or active colostomy;

    25. Autoimmune diseases, for which chronic corticosteroids or immunosuppression therapy may be needed;

    26. Implanted spine stimulator;

    27. Uncontrolled spasticity;

    28. Uncontrolled neuropathic pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSD Medical Center, Division of Neurosurgery San Diego California United States 92103-8893

    Sponsors and Collaborators

    • Neuralstem Inc.

    Investigators

    • Principal Investigator: Joseph Ciacci, MD, UCSD Medical Center, Division of Neurosurgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Neuralstem Inc.
    ClinicalTrials.gov Identifier:
    NCT01772810
    Other Study ID Numbers:
    • NS2010-1
    First Posted:
    Jan 21, 2013
    Last Update Posted:
    Sep 11, 2017
    Last Verified:
    Sep 1, 2017
    Keywords provided by Neuralstem Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 11, 2017