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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2017 by Neuralstem Inc.
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc.
ClinicalTrials.gov Identifier:
NCT01772810
First received: January 14, 2013
Last updated: April 7, 2017
Last verified: April 2017
  Purpose
This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.

Condition Intervention Phase
Spinal Cord Injury (SCI)
Drug: Human spinal cord stem cells.
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Neuralstem Inc.:

Primary Outcome Measures:
  • Incidence of Adverse Events including serious adverse events (SAEs) and clinically significant laboratory abnormalities. [ Time Frame: The primary outcome measure will be assessed over the 6 month study period. ]

Secondary Outcome Measures:
  • Graft survival in the transplant site as determined by MRI and via autopsy, if one is completed. [ Time Frame: An MRI will be performed at Visits 1, 3, 5, 7, and 11 through 22. ]
    Effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.


Other Outcome Measures:
  • EMG, SCIM, ISNC SCI, and Bowel and bladder follow-up [ Time Frame: The exploratory outcome measures of the study will be assessed over a 60 month period. ]
    Compare baseline scores to post-stem cell transplant scores for SCIM, ISNC SCI, bowel and bladder function and EMG.


Estimated Enrollment: 8
Actual Study Start Date: August 2014
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: spinal cord injury (SCI)

Detailed Description:
This is a Phase I, open-label, single-site, safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury (SCI) defined as at least one year but no more than 2 years after traumatic SCI. A maximum of 8 subjects with chronic SCI with American Spinal Injury Association Impairment Scale (AIS) A who meet eligibility criteria will be enrolled. No control group will be included. All subjects will receive spinal cord injections of HSSC: Group A: 4 patients with T2-T12 cord injury. Group B: 4 patients with C5-C7 cord injury. Study duration will be for 6 months for each subject. Post study, all subjects will be followed for additional 54 months by bi-annual visits during which safety assessments will be conducted as specified in the protocol.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Lives within 500 miles of study center

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772810

Contacts
Contact: Dr. Ciacci's Research Group 619-471-3698 nksidhu@ucsd.edu

Locations
United States, California
UCSD Medical Center, Division of Neurosurgery Recruiting
San Diego, California, United States, 92103-8893
Contact: Dr. Ciacci's Research Group    619-471-3698    nksidhu@ucsd.edu   
Principal Investigator: Joseph Ciacci, MD         
Sub-Investigator: Martin Marsala, MD         
Sponsors and Collaborators
Neuralstem Inc.
Investigators
Principal Investigator: Joseph Ciacci, MD UCSD Medical Center, Division of Neurosurgery
  More Information

Additional Information:
Responsible Party: Neuralstem Inc.
ClinicalTrials.gov Identifier: NCT01772810     History of Changes
Other Study ID Numbers: NS2010-1
Study First Received: January 14, 2013
Last Updated: April 7, 2017

Keywords provided by Neuralstem Inc.:
Paralysis due to chronic spinal cord injury (SCI)

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on April 28, 2017