StrokePhase 1NCT02397018
Cord Blood Infusion for Ischemic Stroke
A Phase 1 study testing allogeneic umbilical cord blood in people with Stroke, run by Joanne Kurtzberg, MD at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- allogeneic umbilical cord blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 23 Feb 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An individual is eligible for inclusion if all of the following apply:
- 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.
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- 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.
Who cannot join
- 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
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- 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
- Has current or recent history of alcohol or drug abuse, or stroke associated with drug abuse
- Pregnant as documented by urine or blood test
- Concomitant or Prior Therapies:
- Subjects currently receiving immunosuppressant drugs
- History of prior transfusion reaction
- Currently on dialysis
- Recipient of bone marrow or organ transplant
- Renal insufficiency with serum creatinine >2.0 mg/dL
- 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.
- Any previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy
- Subjects participating in another interventional clinical trial of an investigational therapy within 30 days of screening
- Other:
- Pregnant or lactating women
- Unable to be evaluated for follow up visits
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Houston Methodist
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- allogeneic umbilical cord blood
- Keywords
- stroke, cord blood, umbilical cord blood, hematopoietic stem cells, acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic umbilical cord bloodBiological
Also called cord blood, 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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Umbilical Cord Blood Infusion | Experimental | All subjects in this study will receive an intravenous infusion of ABO/Rh matched umbilical cord blood. Receives: Biological: allogeneic umbilical cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of subjects experiencing any study related Adverse Event (AE) during the 12-month follow-up period
Measured: 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
Measured: 100 days
Secondary outcomes (2)
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 3 months post-infusion
Measured: 3 months post-infusion for the last subject
Change in Infarct Volumes
Describe changes in infarct volumes over the first 3 months post-stroke
Measured: 3 months post-infusion for the last subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMay 2015
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanne Kurtzberg, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joanne Kurtzberg, MD, Duke University
- Investigators
- Joanne Kurtzberg, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397018
- Sponsor's protocol ID
- Pro00059284
- Status last verified
- Oct 2019
- First submitted
- 19 Mar 2015
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29752869
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02397018
- Acronym / sponsor ID
- Pro00059284
- Conditions
- Stroke
- Keywords
- stroke, cord blood, umbilical cord blood, hematopoietic stem cells, acute ischemic stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joanne Kurtzberg, MDUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Umbilical Cord Blood Infusion | Experimental | Biological: allogeneic umbilical cord bloodAll subjects in this study will receive an intravenous infusion of ABO/Rh matched umbilical cord blood. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (29 listed)
- An individual is ineligible to participate if any of the following apply.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic umbilical cord bloodAlso: cord blood, umbilical cord bloodUmbilical 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. | Biological | Allogeneic Umbilical Cord Blood Infusion |
Primary outcome
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
Graft Versus Host Disease
Time frame: 100 days
The proportion of subjects experiencing Graft Versus Host Disease (GVHD) at Day 100 post-infusion
2 secondary outcomes
Change in modified Rankin Score
Time frame: 3 months post-infusion for the last subject
Change in Infarct Volumes
Time frame: 3 months post-infusion for the last subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Results publication: PubMed 29752869Laskowitz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Kurtzberg, M.D. principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing allogeneic umbilical cord blood in people with Stroke, run by Joanne Kurtzberg, MD at 2 sites 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 11 inclusion and 29 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: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 months post-infusion for the last subject). The study lists 2 primary outcomes in all. 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 NCT02397018, 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 17 Oct 2019.