NCT01772810

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

3.9 years

First QC Date

January 14, 2013

Last Update Submit

September 6, 2017

Conditions

Spinal Cord Injury (SCI)

Keywords

Paralysis, spinal cord injury, chronic spinal cord injury, cspine injury, neck injury

Outcome Measures

Primary Outcomes (1)

  • Adverse events and clinically significant laboratory abnormalities

    6 months

Secondary Outcomes (1)

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

    Month 60

Other Outcomes (1)

  • EMG, SCIM, ISNC SCI, and Bowel and bladder follow-up

    60 months

Study Arms (1)

Surgical implantation of human spinal cord stem cells

EXPERIMENTAL

Surgical implantation of human spinal cord derived neural stem cells.

Drug: Human spinal cord stem cells.

Interventions

Human spinal cord stem cells.DRUG

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

Also known as: spinal cord injury (SCI)
Surgical implantation of human spinal cord stem cells

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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
  • 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)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center, Division of Neurosurgery

San Diego, California, 92103-8893, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39626671DERIVED

Related Links

MeSH Terms

Conditions

Spinal Cord InjuriesParalysisNeck Injuries

Interventions

Creb3l2 protein, rat

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Ciacci, MD

    UCSD Medical Center, Division of Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Ciacci's Research Group

CONTACT

844-317-7836 (STEM)alphastemcellclinic@ucsd.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2013

First Posted

January 21, 2013

Study Start

August 1, 2014

Primary Completion

July 1, 2018

Study Completion

December 1, 2022

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

US(1)