Cord Blood Infusion for Ischemic Stroke

October 15, 2019 updated by: Joanne Kurtzberg, MD

Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the safety of a single, intravenous infusion of banked allogeneic umbilical cord blood in subjects within 3-10 days following an acute ischemic stroke. The subjects will not be pre-treated with immunosuppressive agents. The primary objective is safety assessment and the secondary objectives are to determine which outcome measures can be used as primary and secondary endpoints for future randomized Phase 2 clinical trials, and to describe clinical responses, if any. All subjects will receive standard of care acute and rehabilitation treatments while enrolled in this study.

This is a multicenter Phase 1 safety study in patients 18-80 years of age who have sustained a recent ischemic stroke. A total of 10 subjects will be enrolled. Subjects will be given a series of baseline neurological assessments, blood tests, and MRI. 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/kg. Umbilical cord blood will be administered intravenously as a single infusion between 3 and 10 days post-stroke. Subjects will be monitored for 6 hours post-infusion, and follow up will occur 24 hours later. Subsequent follow up phone calls will occur at 1, 6, and 12 months, 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.

Risks of cord blood infusion include infusion-related reactions such as anaphylaxis, urticaria, dyspnea, hypoxia, cough, wheezing, bronchospasm, nausea, vomiting, hives, fever, hypertension, hypotension, bradycardia, tachycardia, rigors, chills, infection, and hemoglobinuria. Less likely, long-term risks include transmission of infection or Graft vs Host Disease.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

An individual is eligible for inclusion if all of the following apply:

  1. Is 18-80 years old
  2. 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
  3. 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
  4. Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dl, and white blood cell count (wbc) >2,500/uL.
  5. Subjects who received tissue plasminogen activator (tPA) or underwent mechanical reperfusion may be included in the study.
  6. Is able to provide consent to study or consent is obtained from the subject's legally authorized representative
  7. 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
  8. Is a good candidate for the trial, in the opinion of the investigator
  9. Agrees to participate in follow up visits
  10. 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.

Exclusion Criteria:

An individual is ineligible to participate if any of the following apply.

Medical Conditions:

  1. 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
  2. Has clinically significant and/or symptomatic hemorrhage associated with stroke
  3. Has new intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion
  4. Has hypotension as defined as the need for IV pressor support of systolic blood pressure <90
  5. Has isolated brain stem stroke
  6. Has pure lacunar stroke
  7. Requires mechanical ventilation
  8. Requires a craniotomy
  9. Has a serious psychiatric or neurological disease which could alter evaluation on functional or cognitive scales
  10. Has an active systemic infection or is HIV positive
  11. Has had an active malignancy within 3 years prior to the start of screening excluding skin cancers other than melanoma
  12. Has known coagulopathy such as Factor V Leyden, AntiPhospholipid Syndrome (APC), Protein C, Protein S deficiency, sickle cell, anticardiolipin antibody, or phospholipid syndrome
  13. Has any concurrent illness or condition that in the opinion of the investigator might interfere with treatment or evaluation of safety
  14. Has current or recent history of alcohol or drug abuse, or stroke associated with drug abuse
  15. Pregnant as documented by urine or blood test

Concomitant or Prior Therapies:

  1. Subjects currently receiving immunosuppressant drugs
  2. History of prior transfusion reaction
  3. Currently on dialysis
  4. Recipient of bone marrow or organ transplant
  5. Renal insufficiency with serum creatinine >2.0 mg/dL
  6. Hepatic insufficiency (bilirubin >2.5mg/dL or transaminases >5x the upper limit of normal). Patients with Gilberts syndrome are eligible for study enrollment if other liver function tests are normal, regardless of bilirubin level.
  7. Any previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy
  8. Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening

Other:

  1. Pregnant or lactating women
  2. Unable to be evaluated for follow up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Allogeneic Umbilical Cord Blood Infusion
All subjects in this study will receive an intravenous infusion of ABO/Rh matched umbilical cord blood.
Biological: allogeneic umbilical cord blood
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.
Other Names:
  • cord blood
  • umbilical cord blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 months post-infusion for the last subject
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
Time Frame: 100 days
The proportion of subjects experiencing Graft Versus Host Disease (GVHD) at Day 100 post-infusion
100 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in modified Rankin Score
Time Frame: 3 months post-infusion for the last subject
The mean change in modified Rankin Score from baseline to 3 months post-infusion
3 months post-infusion for the last subject
Change in Infarct Volumes
Time Frame: 3 months post-infusion for the last subject
Describe changes in infarct volumes over the first 3 months post-stroke
3 months post-infusion for the last subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joanne Kurtzberg, MD

Investigators

  • Principal Investigator: Joanne Kurtzberg, M.D., Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

February 23, 2017

Study Completion (Actual)

February 23, 2017

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 15, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00059284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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