NCT02397018

Brief Summary

This is a phase one study investigating the safety of a single, intravenous infusion of banked allogeneic umbilical cord blood in subjects following an acute ischemic stroke. The cord blood infusion must be given within 3-10 days of the stroke. Follow up phone calls will occur at 1, 6, and 12 months post-infusion, and will include telephone surveys on post-stroke rehabilitation and functioning. A follow up clinic visit at 90 days will include a neurological exam, MRI, and blood tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started May 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

March 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

1.8 years

First QC Date

March 19, 2015

Last Update Submit

October 15, 2019

Conditions

Stroke

Keywords

strokecord bloodumbilical cord bloodhematopoietic stem cellsacute ischemic stroke

Outcome Measures

Primary Outcomes (2)

  • Adverse Events

    Number of subjects experiencing any study related Adverse Event (AE) during the 12-month follow-up period

    12 months post-infusion for the last subject

  • Graft Versus Host Disease

    The proportion of subjects experiencing Graft Versus Host Disease (GVHD) at Day 100 post-infusion

    100 days

Secondary Outcomes (2)

  • Change in modified Rankin Score

    3 months post-infusion for the last subject

  • Change in Infarct Volumes

    3 months post-infusion for the last subject

Study Arms (1)

Allogeneic Umbilical Cord Blood Infusion

EXPERIMENTAL

All subjects in this study will receive an intravenous infusion of ABO/Rh matched umbilical cord blood.

Biological: allogeneic umbilical cord blood

Interventions

allogeneic umbilical cord bloodBIOLOGICAL

Umbilical cord blood units will be selected from a public cord blood bank based on ABO/Rh blood type and cell dose, targeting a range of 0.5 to 5 x 10\^7 total nucleated cells per kilogram. The cord blood unit will be intravenously infused into the subject over 5-30 minutes at a rate not exceeding 5 mL/kg/hr. Subjects will not receive immunosuppressive medications or any other cytoreduction prior to infusion.

Also known as: cord blood, umbilical cord blood
Allogeneic Umbilical Cord Blood Infusion

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is 18-80 years old
  • Has had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the middle cerebral artery (MCA) distribution without a midline shift as detected by magnetic resonance imaging (MRI) as a diffusion-weighted image (DWI) abnormality
  • Has a National Institutes of Health Stroke Scale (NIHSS) score of 8-15 (R) and 8-18 (L) at the time of enrollment with no more than a 4 point increase (worsening of score) from the baseline score compared to 24 hours prior to infusion
  • Subjects must have a platelet count \>100,000/uL, hemoglobin \>8gm/dl, and white blood cell count (wbc) \>2,500/uL.
  • Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the study.
  • Is able to provide consent to study or consent is obtained from the subject's legally authorized representative
  • Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention so that, in the opinion of the investigator, they will not become pregnant during the course of the study
  • Is a good candidate for the trial, in the opinion of the investigator
  • Agrees to participate in follow up visits
  • Has an ABO/Rh matched umbilical cord blood unit with a minimum of 0.5 x 10\^7 total nucleated cells (TNCC)/kg based on the pre-cryopreservation TNCC.

You may not qualify if:

  • An individual is ineligible to participate if any of the following apply.
  • Medical Conditions:
  • Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in a modified Rankin Scale \>1 before stroke or has a pre-existing cognitive deficit
  • Has clinically significant and/or symptomatic hemorrhage associated with stroke
  • Has new intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion
  • Has hypotension as defined as the need for IV pressor support of systolic blood pressure \<90
  • Has isolated brain stem stroke
  • Has pure lacunar stroke
  • Requires mechanical ventilation
  • Requires a craniotomy
  • Has a serious psychiatric or neurological disease which could alter evaluation on functional or cognitive scales
  • Has an active systemic infection or is HIV positive
  • Has had an active malignancy within 3 years prior to the start of screening excluding skin cancers other than melanoma
  • Has known coagulopathy such as Factor V Leyden, AntiPhospholipid Syndrome (APC), Protein C, Protein S deficiency, sickle cell, anticardiolipin antibody, or phospholipid syndrome
  • Has any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Laskowitz DT, Bennett ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, Shpall E, Wilson JM, Troy J, Kurtzberg J. Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke: Clinical Outcomes from a Phase I Safety Study. Stem Cells Transl Med. 2018 Jul;7(7):521-529. doi: 10.1002/sctm.18-0008. Epub 2018 May 12.

    PMID: 29752869RESULT

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Joanne Kurtzberg, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 24, 2015

Study Start

May 1, 2015

Primary Completion

February 23, 2017

Study Completion

February 23, 2017

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations

US(2)