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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01772810
Recruitment Status : Recruiting
First Posted : January 21, 2013
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc.

Tracking Information
First Submitted Date  ICMJE January 14, 2013
First Posted Date  ICMJE January 21, 2013
Last Update Posted Date September 11, 2017
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
Adverse events and clinically significant laboratory abnormalities [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
The primary objective of the study is to determine the safety of human spinal stem cell transplantation for the treatment of paralysis and related symptoms due to chronic spinal cord injury (SCI) [ Time Frame: The primary outcome measure will be assessed over a 60 month period. ]
The primary outcome measure is the incidence of adverse events in the study population.
Change History Complete list of historical versions of study NCT01772810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2017)
Graft survival in the transplant site as determined by MRI (for Group A) and via autopsy, if one is completed. [ Time Frame: Month 60 ]
Effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
The secondary objective of the study is to evaluate the graft survival in the transplant site by MRI. [ Time Frame: An MRI will be performed at Visits 5, 10, 16, 19 and 24. ]
The secondary outcome measures of the study is to evaluate the ability of HSSC transplantation to positively affect AIS level ISNC SCI motor and sensory index scores, bowel and bladder function, pain, UAB IMR scores, SCIM scores, evoked sensory and motor potentials, and electromyogram (EMG).
Current Other Pre-specified Outcome Measures
 (submitted: September 6, 2017)
EMG, SCIM, ISNC SCI, and Bowel and bladder follow-up [ Time Frame: 60 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI
Official Title  ICMJE A Phase 1, Open-label, Single-site, Safety Study of Human Spinal Cord-derived Neural Stem Cell Transplantation for the Treatment of Chronic SCI
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury (SCI)
Intervention  ICMJE Drug: Human spinal cord stem cells.
Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.
Other Name: spinal cord injury (SCI)
Study Arms  ICMJE Experimental: Surgical implantation of human spinal cord stem cells
Surgical implantation of human spinal cord derived neural stem cells.
Intervention: Drug: Human spinal cord stem cells.
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 18, 2013)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

      1. Group A: injury within cord segments T2-T12;
      2. Group B: injury within cord segments C5-C7
    7. Confirmation of bone fusion by CT scan
    8. Agrees to the visit schedule as outlined in the informed consent
    9. 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:

    1. Coagulopathy with INR > 1.4 at the time of screening
    2. Active infection
    3. Active hypotension requiring vasopressor therapy
    4. Skin breakdown over the site of surgery
    5. History of Malignancy (except for non-melanoma skin cancer)
    6. Primary or secondary immune deficiency
    7. 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)
  9. Presence of any of the following conditions:

    1. Current drug abuse or alcoholism
    2. Unstable medical conditions
    3. Unstable psychiatric illness including psychosis and untreated major depression
  10. Any condition that the Investigator or primary physician feels may interfere with participation in the study
  11. Any condition that the surgeon feels may pose complications for the surgery
  12. Known hypersensitivity to basiliximab, tacrolimus or mycophenolate mofetil
  13. Inability to provide informed consent as determined by screening protocol.
  14. Stage III or above decubitus wound, other open wound, or active colostomy;
  15. Autoimmune diseases, for which chronic corticosteroids or immunosuppression therapy may be needed;
  16. Implanted spine stimulator;
  17. Uncontrolled spasticity;
  18. Uncontrolled neuropathic pain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dr. Ciacci's Research Group 844-317-7836 (STEM) alphastemcellclinic@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01772810
Other Study ID Numbers  ICMJE NS2010-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Neuralstem Inc.
Study Sponsor  ICMJE Neuralstem Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joseph Ciacci, MD UCSD Medical Center, Division of Neurosurgery
PRS Account Neuralstem Inc.
Verification Date September 2017

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