Trial record 3 of 3 for:    Ciacci

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Neuralstem Inc.
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc.
ClinicalTrials.gov Identifier:
NCT01772810
First received: January 14, 2013
Last updated: August 23, 2014
Last verified: August 2014
  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)
Device: Human spinal cord stem cells.
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Neuralstem Inc.:

Primary Outcome Measures:
  • The primary outcome measure of the study is to determine the 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. ] [ Designated as safety issue: Yes ]
    The primary outcome measure is the incidence of adverse events in the study population.


Secondary Outcome Measures:
  • The secondary outcome measure of the study is to evaluate the graft survival in the transplant site as determined by MRI (with and without gadolinium contrast) and via autopsy, if one is completed. [ Time Frame: An MRI will be performed at Visits 1, 3, 5, 7, and 11 through 22. ] [ Designated as safety issue: Yes ]
    The secondary outcome measures of the study are to evaluate graft survival in the transplant site and to determine the effectiveness of immunosuppression as determined by absence of donor-specific HLA antibodies.


Other Outcome Measures:
  • Exploratory Outcome Measures [ Time Frame: The exploratory outcome measures of the study will be assessed over a 60 month period. ] [ Designated as safety issue: Yes ]
    The exploratory outcome measure of the study is to compare baseline sensory and motor index scores to post HSSC transplantation sensory and motor index scores. Baseline bowel and bladder function scores compared to the bowel and bladder function scores post transplantation. Baseline evoked sensory or motor potentials or EMG compared to post transplantation evoked potentials or EMG.


Estimated Enrollment: 4
Study Start Date: August 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: February 2016 (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.
Device: 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 4 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. An independent Data Safety Monitoring Board (DSMB) will be convened at approximately 1 month (4 weeks) intervals after the first subject and will review all available safety data for all treated subjects. 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 within cord segments T2-T12
  7. Agrees to the visit schedule as outlined in the informed consent

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. Receipt of any investigational drug or device within 30 days prior to surgery
  5. Receipt of any cell infusion other than blood transfusion
  6. 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
  7. Any condition that the Investigator or primary physician feels may interfere with participation in the study
  8. Any condition that the surgeon feels may pose complications for the surgery
  9. Inability to provide informed consent as determined by screening protocol.
  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: Amber Faulise, B.S. 858-657-5175 rfaulise@ucsd.edu

Locations
United States, California
UCSD Medical Center, Division of Neurosurgery Recruiting
San Diego, California, United States, 92103-8893
Contact: Joseph Ciacci, MD       jciacci@ucsd.edu   
Contact: Martin Marsala, MD       mmarsala@ucsd.edu   
Principal Investigator: Joseph Ciacci, MD         
Sub-Investigator: Martin Marsala, MD         
Sponsors and Collaborators
Neuralstem Inc.
  More Information

Additional Information:
No publications provided

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: August 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Neuralstem Inc.:
Paralysis due to 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 September 22, 2014