NCT02237547

Brief Summary

Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

September 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

4.3 years

First QC Date

September 9, 2014

Last Update Submit

August 8, 2017

Conditions

Spinal Cord Injury

Keywords

spinal cord injurymesenchymalbone marrowmononuclear cellsstem cellsumbilical cord

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    12 and 52 weeks after final treatment

    12 weeks, 52 weeks

Secondary Outcomes (2)

  • Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline

    12 weeks, 52 weeks

  • Number of subjects with a change in Frankel Scale score from baseline

    12 weeks, 52 weeks

Study Arms (1)

IV and IT UC-MSC and BMMC

EXPERIMENTAL

Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells

Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells

Interventions

Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cellsBIOLOGICAL
IV and IT UC-MSC and BMMC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women between age 18 and 50
  • Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.
  • Willingness to undergo bone marrow derived autologous cell therapy.
  • Ability and willingness to make regular visits to hospital and follow ups during the protocol procedure and comply with all medical instructions
  • Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance Imaging (MRI) and injury level below C4
  • ASIA impairment scale from A - C
  • Must have proof of health insurance in country of residence.
  • Signed informed consent

You may not qualify if:

  • Pre- existing or current systemic disease such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus (HIV)
  • History of life threatening allergic- or immune-mediated reaction
  • Hemodynamic instability
  • Peripheral muscular dystrophy
  • Lactating or pregnant woman
  • Women capable of childbearing unwilling to use multiple forms of contraception
  • Alcohol drug abuse /dependence
  • Positive test result for hepatitis A and Hepatitis B OR C
  • Major-traumatic brain injury and psychiatric illness
  • Open injuries
  • Active infectious diseases
  • Life expectancy of less than one year due to terminal condition
  • Neurodegenerative diseases
  • Primary hematologic diseases
  • Any of the following medications that cannot be discontinued one week prior to the first stem cell administration and throughout the course of treatment. (1 week before visit 2 through one week after visit 12)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cell Institute

Panama City, Panama

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Nelson Novarro, MD

    PRINCIPAL INVESTIGATOR
0

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

September 9, 2014

First Posted

September 11, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2019

Study Completion

October 1, 2019

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

PA(1)