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Spinal Cord Injury (SCI)Phase 1SCINCT01772810

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

A Phase 1 study testing Human spinal cord stem cells. in people with Spinal Cord Injury (SCI), run by Neuralstem Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injury (SCI)
What is being tested?
Human spinal cord stem cells.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Aug 2014to Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Lives within 500 miles of study center (For Group B)
  • 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
  • Men and women 18-65 years old
  • 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)
  • At least 1 year but no more than 2 years from time of injury at the time of surgery
  • 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
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  • Neurologic level of injury:
  • Group A: injury within cord segments T2-T12;
  • Group B: injury within cord segments C5-C7
  • Confirmation of bone fusion by CT scan
  • Agrees to the visit schedule as outlined in the informed consent
  • 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.

Who cannot join

  • SCI due to penetrating trauma such as gun shot or stabbing wound
  • SCI injuries involving complete spinal cord transection
  • Etiology of paraplegia or weakness related to other or additional neurologic process
  • 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
  • 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
  • Receipt of any investigational drug or device within 30 days prior to surgery
Show all 28Show fewer
  • Receipt of any cell infusion other than blood transfusion
  • Any concomitant medical disease or condition noted below:
  • Coagulopathy with INR > 1.4 at the time of screening
  • Active infection
  • Active hypotension requiring vasopressor therapy
  • Skin breakdown over the site of surgery
  • History of Malignancy (except for non-melanoma skin cancer)
  • Primary or secondary immune deficiency
  • 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)
  • Presence of any of the following conditions:
  • Current drug abuse or alcoholism
  • Unstable medical conditions
  • Unstable psychiatric illness including psychosis and untreated major depression
  • Any condition that the Investigator or primary physician feels may interfere with participation in the study
  • Any condition that the surgeon feels may pose complications for the surgery
  • Known hypersensitivity to basiliximab, tacrolimus or mycophenolate mofetil
  • Inability to provide informed consent as determined by screening protocol.
  • Stage III or above decubitus wound, other open wound, or active colostomy;
  • Autoimmune diseases, for which chronic corticosteroids or immunosuppression therapy may be needed;
  • Implanted spine stimulator;
  • Uncontrolled spasticity;
  • Uncontrolled neuropathic pain

Trial locations and contacts

1 site in 1 country.

Dr. Ciacci's Research Group contact

844-317-7836 (STEM)

alphastemcellclinic@ucsd.edu

United States1 site, 1 recruiting

  • UCSD Medical Center, Division of Neurosurgery

    San Diego, California, 92103-8893

    Dr. Ciacci's Research Group, 844-317-7836, alphastemcellclinic@ucsd.edu

    Joseph Ciacci, MD

    Recruiting

Other trials in United States

About this study

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

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

Read the 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.

Being tested
Human spinal cord stem cells.
Keywords
Paralysis, spinal cord injury, chronic spinal cord injury, cspine injury, neck injury
Medical subject headings
Spinal Cord Injuries, Paralysis, Neck Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human spinal cord stem cells.Drug

    Also called spinal cord injury (SCI)

    Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.

Study groups in NCT01772810
Study groupRoleWhat they receive
Surgical implantation of human spinal cord stem cellsExperimentalSurgical implantation of human spinal cord derived neural stem cells.
Receives: Drug: Human spinal cord stem cells.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events and clinically significant laboratory abnormalities

    Measured: 6 months

Secondary outcomes (1)

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

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

    Measured: Month 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2013 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2018 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01772810
Sponsor's protocol ID
NS2010-1
Acronym
SCI
Status last verified
Sep 2017
First submitted
14 Jan 2013
Last updated
11 Sep 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Martin JR, Cleary D, Abraham ME, Mendoza M, Cabrera B, Jamieson C, Marsala M, Ciacci JD. Long-term clinical and safety outcomes from a single-site phase 1 study of neural stem cell transplantation for chronic thoracic spinal cord injury. Cell Rep Med. 2024 Dec 17;5(12):101841. doi: 10.1016/j.xcrm.2024.101841. Epub 2024 Dec 2.

    PubMed 39626671

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Human spinal cord stem cells. in people with Spinal Cord Injury (SCI), run by Neuralstem Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dr. Ciacci's Research Group (844-317-7836 (STEM), alphastemcellclinic@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events and clinically significant laboratory abnormalities (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01772810, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.

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