StrokePhase 2CoBIS 2NCT03004976
Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke
A Phase 2 study testing Umbilical Cord Blood in people with Stroke and Stroke, Acute, run by Joanne Kurtzberg, MD at 6 sites in United States.
Trial summary
The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Stroke, Acute, Brain Injury, Acute
- What is being tested?
- Umbilical Cord Blood
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 6 sitesUnited States
- Study dates
- 14 Mar 2017to 27 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years old
- Recent, acute, cortical, hemispheric, ischemic stroke in the MCA (middle cerebral artery) distribution without a clinically significant midline shift as detected by MRI as a DWI (diffusion-weighted imaging) abnormality. If unable to obtain a MRI scan, patients may be included if there is clear evidence of ischemic cortical involvement in the MCA distribution demonstrated by computed tomography and a clinical exam consistent with cortical involvement.
- NIHSS 6-15 (R) and 6-20 (L) at the time of informed consent. Subjects with a >4-point increase of NIHSS from time of consent (worsening of score) will not be eligible for infusion.
- Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dL, absolute lymphocyte count (ALC) ≥ 1200 for African American patients and ≥1500 for all other racial-ethnic groups, and WBC (white blood cell) count >2,500/uL OR Historical pre-stroke value of ALC ≥ 1200 for African American and ≥1500 for all other racial-ethnic groups within 6 months of stroke
- -And- a post stroke ALC value of ≥ 1000, platelet count >100,000/uL, hemoglobin >8gm/dL and WBC >2,500/uL.
- Subjects who received tPA (Tissue plasminogen Activator) or underwent endovascular reperfusion may be included in the study
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- Able to provide consent to study or consent is obtained from the patient's legal 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
- ABO/Rh and race matched CBU(s) with a minimum of 0.5 x 10^7 TNCC/kg based on the pre-cryopreservation TNCC is available for infusion
- Has not had a disease or therapy that would compromise current immune function.
- Has a serum creatinine ≤2 mg/dL OR Glomerular Filtration Rate (GFR) ≥30mL/min
Who cannot join
- An individual is ineligible to participate if any of the following apply:
- Exclusionary Medical Conditions:
- 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
- Clinically significant and/or symptomatic hemorrhage associated with stroke
- Evidence of significant midline shift as assessed by CT or MRI who are felt to be at high risk for neurological decompensation or need for decompressive hemicraniectomy due to hemispheric edema
- New intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion
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- Hypotension as defined as the need for IV pressor support of SBP (systolic blood pressure) <90
- Isolated brain stem stroke
- Pure lacunar stroke
- At time of consent, patients who are mechanically ventilated or, at the investigator's discretion are felt to be likely to need mechanical ventilation are excluded.
- Requires a craniotomy
- Serious psychiatric or neurological disease which could alter evaluation on functional or cognitive scales
- Active systemic infection that is felt, at the discretion of the Investigator, to place the patient at increased risk for participation in this study
- Documentation of human immunodeficiency virus positive (HIV+) status in the medical record
- Active malignancy within 3 years prior to the start of screening excluding skin cancers other than melanoma
- Known hypercoagulable state or coagulopathy deficiencies such as Factor V Leiden, Antiphospholipid Syndrome (APC), Protein C, Protein S, anticardiolipin antibody, phospholipid syndrome or Sickle Cell Disease
- History of or currently active autoimmune disease, or current immunomodulatory therapy or a recipient of immunomodulatory therapy in the past year.
- Concurrent illness or condition that in the opinion of the Investigator might interfere with treatment or evaluation of safety
- Current or recent history of alcohol or drug abuse, or stroke associated with drug abuse that Investigator feels may impair therapy or assessments
- Pregnant as documented by blood test
- Prohibited Concomitant or Prior Therapies
- Patients currently receiving immunosuppressant drugs, not including glucocorticoid taper, topical/inhaled glucocorticoids
- History of prior transfusion reaction
- Currently on dialysis
- Recipient of bone marrow or organ transplant
- Hepatic insufficiency (bilirubin >2.5mg/dL or transaminases >5x the ULN) Patients with Gilberts syndrome are eligible for study enrollment if other liver function tests are normal, regardless of bilirubin level
- Previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy
- Participating in another interventional clinical trial of an investigational therapy within 30 days of consent.
- Other Exclusion Criteria
- Pregnant or lactating women
- Unable or unwilling to be evaluated for follow-up visits
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University School of Medicine
Atlanta, Georgia, 30303
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida Health Shands Hospital
Gainesville, Florida, 32610
Houston Methodist
Houston, Texas, 77030
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke - CoBIS 2
The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.
Read the detailed description
This is a multicenter, placebo controlled, randomized, double blinded Phase 2 study in 100 subjects 18-90 years of age who have sustained a recent ischemic stroke. Potential subjects can be screened and consented the day of their stroke (Day 1). Treatment with umbilical cord blood (UCB) cells or placebo will be administered intravenously as a single infusion as early as 3 days but no later than 10 days after the patient's stroke. UCB units will be selected from an accredited U.S. public cord bank based on blood type, race and a targeted cell dose ranging between 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg. Study subjects will not receive immunosuppressive or myeloablative medications prior to infusion of the cord blood or placebo.
All subjects, families and medical staff will be blinded to treatment arm. When a subject is randomized to study drug at a clinical site without a cord blood bank, the selected cord blood units (CBU) will be shipped frozen overnight to the site. Once selected and available on site, each CBU will be thawed, washed, tested, released and infused intravenously using common standard operating procedures (SOPs) at all sites. For subjects randomized to placebo, a diluent with the same appearance and odor as a CBU will be prepared.
Patients will have baseline magnetic resonance imaging (MRI) and will be assessed at 1, 3, 6, and 12 months for functional outcomes. All patients will receive standard of care therapy while enrolled in this study and all subjects will be strongly encouraged to participate in rehabilitative therapy.
The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows:
- To describe the safety and tolerability of a single IV infusion of unrelated donor UCB in patients with ischemic stroke
- To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement of neurological symptoms following ischemic stroke
- To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement in quality of life and emotional and cognitive status in patients with ischemic stroke
- Conditions
- Stroke, Stroke, Acute, Brain Injury, Acute
- Being tested
- Umbilical Cord Blood, Placebo
- Keywords
- hematopoietic stem cells, umbilical cord blood, stroke, ischemic stroke
- Medical subject headings
- Stroke, Brain Injuries, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord BloodBiological
Also called cord blood, hematopoietic stem cells
Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.
PlaceboOther
The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood | Experimental | A single intravenous infusion of umbilical cord blood within 3-10 days following stroke. Receives: Biological: Umbilical Cord Blood |
| Placebo | Placebo comparator | A single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift in Modified Rankin Scale (mRS)
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Measured: baseline to 3 months post infusion
Secondary outcomes (23)
Number of Infusion Reactions
Measured: up to 1 year post infusion
Number of Product-related Infections
Measured: up to 1 year post infusion
Number of Alloimmunization Events
Measured: up to 1 year post infusion
Number of Graft vs. Host Disease Events
Measured: up to 1 year post infusion
Number of Study Related and Unexpected Adverse Events (AEs)
Measured: up to 1 year post infusion
Mortality
Measured: up to 1 year post infusion
Number of Participants With Functional Independence
Functional independence at 90 days defined as a 90-day mRS (modified Rankin Scale) score of 0, 1, or 2. The mRS has a range of 0 to 5, where lower scores indicate a better outcome.
Measured: 90 days post infusion
Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Measured: baseline to 30 days post infusion
Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
Measured: baseline to 180 days post infusion
The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days
The NIHSS has a range of 0 to 42, where higher scores indicate greater impairment.
Measured: 90 days post infusion
Barthel Index (BI) Score at 90 Days
The Barthel Index assesses functional independence, generally in stroke patients. The BI has a range of 0 to 100 with 0 indicating total dependency and 100 indicating complete independence.
Measured: 90 days post infusion
Stroke Impact Scale-16 (SIS-16) Score at 90 Days
The SIS-16 has a range of 0 to 100 with higher scores indicating a higher quality of life.
Measured: 90 days post infusion
The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days
The EQ-5D-3L VAS ranges from 0 to 100 with 0 being the worst possible health status and 100 being the best possible health status.
Measured: 90 days post infusion
Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days
The PHQ 8 has a range of 0 to 24 with 0 indicating no depression and 24 indicating severe depression.
Measured: 90 days post infusion
Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion
The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.
Measured: 30 days post infusion
Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion
The TICS has a range of 0 to 41 with a higher score indicating better cognitive status.
Measured: 1 year post infusion
Trail Making Test Score at 90 Days Post Infusion (Trail A)
Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. Reported in seconds needed to complete Trail A.
Measured: 90 days post infusion
Trail Making Test Score at 90 Days Post Infusion (Trail B)
Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. Reported in seconds needed to complete Trail B.
Measured: 90 days post infusion
Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion
The MoCA has a range of 0 to 30 with lower scores indicating more severe cognitive impairment.
Measured: 90 days post infusion
Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion
The HVLT-R is a sum of three trials involving word recall. It has a total range of 0 to 36 with higher scores indicating better recall and greater cognition.
Measured: 90 days post infusion
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
For all sub-components (Physical Functioning, Role Limitations Due to Physical Health, Role Limitations Due to Emotional Problems, Energy/Fatigue, Emotional Well-being, Social Functioning, Pain, and General Health), a higher score indicates better health. Scales are standardized to obtain a score ranging from 0 to 100 and a mean score of 50 has been articulated as a normative value for all scales.
Measured: 90 days post infusion
Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion
The COWAT is a verbal fluency test in which participants are asked to say as many words as possible from a given category and in a specified timeframe (typically 60 seconds). Reported as the total number of words produced for F, A, and S. More words indicates better cognition.
Measured: 90 days post infusion
Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion
The SDMT is a measure of processing speed wherein the participant is given 120 seconds to orally match symbols with digits as quickly as possible. Reported as the number of correct associations where a larger number indicates better cognition.
Measured: 90 days post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study start14 Mar 2017
- Primary completion17 Jul 2020
- Study completion27 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joanne Kurtzberg, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Marcus Foundation, Emory University, M.D. Anderson Cancer Center
- Responsible party
- Sponsor-investigator, Joanne Kurtzberg, MD, Duke University
- Investigators
- Joanne Kurtzberg, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004976
- Sponsor's protocol ID
- Pro00077580
- Acronym
- CoBIS 2
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2016
- Last updated
- 6 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke - CoBIS 2
- ClinicalTrials.gov ID
- NCT03004976
- Acronym / sponsor ID
- CoBIS 2 / Pro00077580
- Conditions
- Stroke, Stroke, Acute, Brain Injury, Acute
- Keywords
- hematopoietic stem cells, umbilical cord blood, stroke, ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Joanne Kurtzberg, MDUniversity, hospital or other
- Collaborators
- The Marcus Foundation, Emory University, M.D. Anderson Cancer Center
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 27 Mar 2021 (actual)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Posted 23 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke. Subjects will not receive immunosuppressive or myeloablative medications prior to the infusion. Subjects will be followed for one year post infusion for safety and efficacy. Assessments will examine safety and tolerability of the infusion, change in neurological symptoms, change in quality of life, and emotional and cognitive status. Assessments will occur at 24 hours post infusion, and at 30, 90, 180 and 365 days post infusion.
Detailed description
This is a multicenter, placebo controlled, randomized, double blinded Phase 2 study in 100 subjects 18-90 years of age who have sustained a recent ischemic stroke. Potential subjects can be screened and consented the day of their stroke (Day 1). Treatment with umbilical cord blood (UCB) cells or placebo will be administered intravenously as a single infusion as early as 3 days but no later than 10 days after the patient's stroke. UCB units will be selected from an accredited U.S. public cord bank based on blood type, race and a targeted cell dose ranging between 0.5 to 5 x 10^7 total nucleated cell count (TNCC)/kg. Study subjects will not receive immunosuppressive or myeloablative medications prior to infusion of the cord blood or placebo.
All subjects, families and medical staff will be blinded to treatment arm. When a subject is randomized to study drug at a clinical site without a cord blood bank, the selected cord blood units (CBU) will be shipped frozen overnight to the site. Once selected and available on site, each CBU will be thawed, washed, tested, released and infused intravenously using common standard operating procedures (SOPs) at all sites. For subjects randomized to placebo, a diluent with the same appearance and odor as a CBU will be prepared.
Patients will have baseline magnetic resonance imaging (MRI) and will be assessed at 1, 3, 6, and 12 months for functional outcomes. All patients will receive standard of care therapy while enrolled in this study and all subjects will be strongly encouraged to participate in rehabilitative therapy.
The primary objective of the study is to determine, in a randomized, placebo controlled trial, the efficacy of a single intravenous (IV) infusion of unrelated donor UCB for improving functional outcomes in patients with ischemic stroke. The secondary objectives are as follows:
- To describe the safety and tolerability of a single IV infusion of unrelated donor UCB in patients with ischemic stroke
- To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement of neurological symptoms following ischemic stroke
- To evaluate the efficacy of a single IV infusion of unrelated donor UCB for improvement in quality of life and emotional and cognitive status in patients with ischemic stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood | Experimental | Biological: Umbilical Cord BloodA single intravenous infusion of umbilical cord blood within 3-10 days following stroke. |
| Placebo | Placebo comparator | Other: PlaceboA single intravenous infusion of diluent with the same appearance and odor as a cord blood unit within 3-10 days following stroke. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18-90 years old
- Recent, acute, cortical, hemispheric, ischemic stroke in the MCA (middle cerebral artery) distribution without a clinically significant midline shift as detected by MRI as a DWI (diffusion-weighted imaging) abnormality. If unable to obtain a MRI scan, patients may be included if there is clear evidence of ischemic cortical involvement in the MCA distribution demonstrated by computed tomography and a clinical exam consistent with cortical involvement.
- NIHSS 6-15 (R) and 6-20 (L) at the time of informed consent. Subjects with a >4-point increase of NIHSS from time of consent (worsening of score) will not be eligible for infusion.
- Subjects must have a platelet count >100,000/uL, hemoglobin >8gm/dL, absolute lymphocyte count (ALC) ≥ 1200 for African American patients and ≥1500 for all other racial-ethnic groups, and WBC (white blood cell) count >2,500/uL OR Historical pre-stroke value of ALC ≥ 1200 for African American and ≥1500 for all other racial-ethnic groups within 6 months of stroke
- -And- a post stroke ALC value of ≥ 1000, platelet count >100,000/uL, hemoglobin >8gm/dL and WBC >2,500/uL.
Key exclusion criteria (31 listed)
- 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
- Clinically significant and/or symptomatic hemorrhage associated with stroke
- Evidence of significant midline shift as assessed by CT or MRI who are felt to be at high risk for neurological decompensation or need for decompressive hemicraniectomy due to hemispheric edema
- New intracranial hemorrhage, edema, or mass effect that may place patient at increased risk for secondary deterioration when assessed prior to infusion
- Hypotension as defined as the need for IV pressor support of SBP (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 |
|---|---|---|
| Umbilical Cord BloodAlso: cord blood, hematopoietic stem cellsUmbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg. | Biological | Umbilical Cord Blood |
| PlaceboThe placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm. | Other | Placebo |
Primary outcome
Shift in Modified Rankin Scale (mRS)
Time frame: baseline to 3 months post infusion
The Modified Rankin Score (mRS) is a disability scale with possible scores ranging from 0 to 6, where 6 = death. Since a shift downward in the mRS scale is considered a clinical improvement, shift scores are calculated from baseline to ensure that, for hypothesis testing purposes, larger shift values represent more clinically desirable outcomes.
23 secondary outcomes
Number of Infusion Reactions
Time frame: up to 1 year post infusion
Number of Product-related Infections
Time frame: up to 1 year post infusion
Number of Alloimmunization Events
Time frame: up to 1 year post infusion
Number of Graft vs. Host Disease Events
Time frame: up to 1 year post infusion
Number of Study Related and Unexpected Adverse Events (AEs)
Time frame: up to 1 year post infusion
Mortality
Time frame: up to 1 year post infusion
Number of Participants With Functional Independence
Time frame: 90 days post infusion
Shift in Modified Rankin Scale (mRS) From Baseline to 30 Days Post Infusion
Time frame: baseline to 30 days post infusion
Shift in Modified Rankin Scale (mRS) From Baseline to 180 Days Post Infusion
Time frame: baseline to 180 days post infusion
The National Institutes of Health Stroke Scale (NIHSS) Score at 90 Days
Time frame: 90 days post infusion
Barthel Index (BI) Score at 90 Days
Time frame: 90 days post infusion
Stroke Impact Scale-16 (SIS-16) Score at 90 Days
Time frame: 90 days post infusion
The European Quality of Life (EQ-5D-3L) Visual Analogue Score (VAS) at 90 Days
Time frame: 90 days post infusion
Patient Health Questionnaire Scale (PHQ 8) Score at 90 Days
Time frame: 90 days post infusion
Telephone Interview for Cognitive Status (TICS) Total Score at 30 Days Post Infusion
Time frame: 30 days post infusion
Telephone Interview for Cognitive Status (TICS) Total Score at 1 Year Post Infusion
Time frame: 1 year post infusion
Trail Making Test Score at 90 Days Post Infusion (Trail A)
Time frame: 90 days post infusion
Trail Making Test Score at 90 Days Post Infusion (Trail B)
Time frame: 90 days post infusion
Montreal Cognitive Assessment (MoCA) Score at 90 Days Post Infusion
Time frame: 90 days post infusion
Hopkins Verbal Learning Test-Revised (HVLT-R) Score at 90 Days Post Infusion
Time frame: 90 days post infusion
Short Form 36 Health Survey (SF-36) Scores at 90 Days Post Infusion
Time frame: 90 days post infusion
Controlled Oral Word Association Test (COWAT) Score at 90 Days Post Infusion
Time frame: 90 days post infusion
Oral Symbol Digit Modalities Test (SDMT) Score at 90 Days Post Infusion
Time frame: 90 days post infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Duke University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical Cord Blood in people with Stroke and Stroke, Acute, run by Joanne Kurtzberg, MD at 6 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 13 inclusion and 31 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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Shift in Modified Rankin Scale (mRS) (time frame: baseline to 3 months post infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2022.