Acute Ischemic StrokePhase 1NCT03735277
Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects With Acute Ischemic Stroke
A Phase 1 study testing HPC, Cord Blood in people with Acute Ischemic Stroke, run by BHI Therapeutic Sciences at 1 site in United States.
Trial summary
This is a phase one study investigating the safety and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- HPC, Cord Blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2021to Jul 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects are eligible for the study if all of the following criteria are met:
- Subject is ≥ 18 years old
- Has had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the MCA distribution without a midline shift as detected by MRI as a diffusion-weighted image (DWI) abnormality
- Has a persistent neurological deficit (NIHSS ≥ 7) at the time of enrollment with no more than a 4-point increase (worsening of score) from the screening baseline score compared to NIHSS baseline score at 24 hours prior to infusion.
- A platelet count > 100,000/µL, hemoglobin > 8 g/dL, and white blood cell count (WBC) > 2500/µL
- Subjects who received tPA or underwent mechanical reperfusion may be included in the study
Show all 10Show fewer
- 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 study, in the opinion of the investigator
- Agrees to participate in follow-up visits
Who cannot join
- Subjects are excluded from the study if any of the following criteria are met:
- Medical Conditions
- Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in an mRS > 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 the subject at increased risk for secondary deterioration when assessed prior to infusion
- Has hypotension as defined as the need for intravenous pressor support of systolic blood pressure < 90 mm Hg
Show all 38Show fewer
- Has isolated brain stem stroke
- Has pure lacunar stroke
- Requires mechanical ventilation
- Requires a craniotomy
- Has a serious psychiatric or neurological disease that could alter evaluation on functional or cognitive scales
- Has an active systemic infection or is human immunodeficiency virus (HIV) positive or hepatitis C 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 (APS), 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 a life expectancy < 6 months
- Has current or recent history of alcohol or drug abuse, or stroke associated with drug abuse
- Pregnant as documented by urine or blood test
- Renal insufficiency with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
- Hepatic insufficiency (bilirubin > 2.5 mg/dL or transaminases > 3 × the upper limit of normal). Subjects with Gilbert's syndrome are eligible for study enrollment if other liver function tests are normal, regardless of bilirubin level
- Uncontrolled or poorly controlled type 1 or type 2 diabetes with HbA1c > 7%
- Has a history of impaired hemostasis or has a prothrombin time > 14 seconds/international normalized ratio (INR) > 1.3 second and activated partial thromboplastin time (aPTT) of > 70 seconds.
- Has a severe persistent neurological deficit (NIHSS > 24) at the time of enrollment or 24 hours prior to infusion.
- Has New York Heart Association Class III or IV congestive heart failure.
- Concomitant or Prior Therapies
- Subjects currently receiving immunosuppressant drugs
- Clinical signs and symptoms of infection requiring antibiotic therapy at the time of enrollment that prevent adequate completion of study-related assessments as judged by the investigator
- Current therapy with anabolic steroids or appetite stimulants
- History of prior transfusion reaction
- History of intolerance or allergic response to similar biological products
- Known sensitivity to dimethyl sulfoxide (DMSO), Dextran 40, or plasma proteins
- Currently on dialysis
- Recipient of bone marrow or organ transplant
- Any previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy
- Subjects participating in another interventional clinical study of an investigational therapy within 30 days of screening
- Other
- Lactating women
- Unable to be evaluated for follow-up visits
Trial locations and contacts
1 site in 1 country.
United States1 site
BHI Therapeutic Sciences
Hackensack, New Jersey, 07601
Brian Mehling, MD, 201-342-7662, mmanvelyan@bluehorizoninternational.com
About this study
Official title: Evaluation of the Safety and Efficacy of HPC, Cord Blood
This is a phase one study investigating the safety and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Treatment period consisting of 3 sessions of both intravenous infusion and intrathecal injection (or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection). Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 3 months, 6 months and 12 months will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.
Read the detailed description
The primary objective of the study is to evaluate the safety of HPC, Cord Blood (administered via intravenous infusion and intrathecal injection, or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection) in subjects with acute ischemic stroke. The secondary objective is to evaluate the efficacy of HPC, Cord Blood (as assessed by changes in neurological tests and cerebral infarct volume as measured by diffusion-weighted magnetic resonance imaging (MRI)) in subjects with acute ischemic stroke.
This is a prospective, open-label, single-center, exploratory clinical study in subjects ≥ 18 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.
All subjects will be administered only ABO- and Rh-matched units of HPC, Cord Blood. Subjects will not be matched for human leukocyte antigen (HLA)-typing. For each administration of HPC, cord blood, the total dose (2.5 × 10^7 cells/kg; 150 × 10^7 cells) will be split for intrathecal injection followed immediately by intravenous infusion. HPC, Cord Blood will be administered via intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Intravenous infusion in conjunction with mannitol will be used in instances where a subject is unable to tolerate intrathecal administration. Treatment period consisting of 3 sessions, timed 5 to 12 days apart. Subjects will be monitored for 6 hours post-infusion, and follow up will occur 24 hours after each therapy session. Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 2 weeks, 3 months, 6 months, and 12 months after the first intravenous/intrathecal treatment will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.
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
- Acute Ischemic Stroke
- Being tested
- HPC, Cord Blood
- Keywords
- Human Umbilical Cord Blood, Hematopoietic stem cells
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPC, Cord BloodBiological
Also called Allogeneic umbilical cord blood, hematopoietic stem cells
HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters. The exact precryopreservation nucleated cell content is provided on the container label and accompanying records.
| Study group | Role | What they receive |
|---|---|---|
| HPC, Cord Blood | Experimental | HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters. Receives: Biological: HPC, 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) (including clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examination findings) during the 12-month follow-up period
Measured: 12 months post first administration
Graft Versus Host Disease
Number of subjects experiencing Graft Versus Host Disease (GVHD) at 12-month follow-up period
Measured: 12 months post first administration
Secondary outcomes (12)
Change in National Institutes of Health Stroke Scale
The mean change in National Institutes of Health Stroke Scale from baseline to 3 months post-administration
Measured: 3 months post first administration
Change in National Institutes of Health Stroke Scale
The mean change in National Institutes of Health Stroke Scale from baseline to 6 months post-administration
Measured: 6 months post first administration
Change in National Institutes of Health Stroke Scale
The mean change in National Institutes of Health Stroke Scale from baseline to 12 months post-administration
Measured: 12 months post first administration
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 3 months post-administration
Measured: 3 months post first administration
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 6 months post-administration
Measured: 6 months post first administration
Change in modified Rankin Score
The mean change in modified Rankin Score from baseline to 12 months post-administration
Measured: 12 months post first administration
Change in Barthel Index
The mean change in Barthel Index score from baseline to 3 months post-administration
Measured: 3 months post first administration
Change in Barthel Index
The mean change in Barthel Index score from baseline to 6 months post-administration
Measured: 6 months post first administration
Change in Barthel Index
The mean change in Barthel Index score from baseline to 12 months post-administration
Measured: 12 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Describe changes in infarct volumes from baseline to 3 months post-administration
Measured: 3 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Describe changes in infarct volumes from baseline to 6 months post-administration
Measured: 6 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Describe changes in infarct volumes from baseline to 12 months post-administration
Measured: 12 months post first administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start6 Mar 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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 (estimated)
Sponsor and investigators
- Lead sponsor
- BHI Therapeutic Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Mehling, BHI Therapeutic Sciences
- Investigators
- Brian Mehling, MD, Principal investigator, BHI Therapeutic Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735277
- Sponsor's protocol ID
- BHI17-IS-A
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2018
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of HPC, Cord Blood
- ClinicalTrials.gov ID
- NCT03735277
- Acronym / sponsor ID
- BHI17-IS-A
- Conditions
- Acute Ischemic Stroke
- Keywords
- Human Umbilical Cord Blood, Hematopoietic stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BHI Therapeutic SciencesUniversity, hospital or other
- Study start
- 6 Mar 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 8 Nov 2018 (actual)
- 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 and efficacy profile of allogeneic cord blood hematopoietic progenitor cells (HPC, Cord Blood), when administered by intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Treatment period consisting of 3 sessions of both intravenous infusion and intrathecal injection (or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection). Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 3 months, 6 months and 12 months will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.
Detailed description
The primary objective of the study is to evaluate the safety of HPC, Cord Blood (administered via intravenous infusion and intrathecal injection, or intravenous infusion in conjunction with mannitol for subjects unable to tolerate intrathecal injection) in subjects with acute ischemic stroke. The secondary objective is to evaluate the efficacy of HPC, Cord Blood (as assessed by changes in neurological tests and cerebral infarct volume as measured by diffusion-weighted magnetic resonance imaging (MRI)) in subjects with acute ischemic stroke.
This is a prospective, open-label, single-center, exploratory clinical study in subjects ≥ 18 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.
All subjects will be administered only ABO- and Rh-matched units of HPC, Cord Blood. Subjects will not be matched for human leukocyte antigen (HLA)-typing. For each administration of HPC, cord blood, the total dose (2.5 × 10^7 cells/kg; 150 × 10^7 cells) will be split for intrathecal injection followed immediately by intravenous infusion. HPC, Cord Blood will be administered via intravenous infusion and intrathecal injection, in subjects who have sustained an acute ischemic stroke within the past 9 days. Intravenous infusion in conjunction with mannitol will be used in instances where a subject is unable to tolerate intrathecal administration. Treatment period consisting of 3 sessions, timed 5 to 12 days apart. Subjects will be monitored for 6 hours post-infusion, and follow up will occur 24 hours after each therapy session. Follow-up phone calls for adverse event (AE) assessment will be conducted at 1 week, 1 month, and 2 months after the first intravenous/intrathecal treatment. A follow up clinic visit at 2 weeks, 3 months, 6 months, and 12 months after the first intravenous/intrathecal treatment will include a neurological exam, MRI, and clinical laboratory tests/urinalysis.
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 |
|---|---|---|
| HPC, Cord Blood | Experimental | Biological: HPC, Cord BloodHPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is ≥ 18 years old
- Has had a recent (within the past 9 days), acute, cortical, hemispheric, ischemic stroke in the MCA distribution without a midline shift as detected by MRI as a diffusion-weighted image (DWI) abnormality
- Has a persistent neurological deficit (NIHSS ≥ 7) at the time of enrollment with no more than a 4-point increase (worsening of score) from the screening baseline score compared to NIHSS baseline score at 24 hours prior to infusion.
- A platelet count > 100,000/µL, hemoglobin > 8 g/dL, and white blood cell count (WBC) > 2500/µL
- Subjects who received tPA or underwent mechanical reperfusion may be included in the study
Key exclusion criteria (38 listed)
- Medical Conditions
- Has a medical history of neurological or orthopedic pathology with a deficit as a consequence that results in an mRS > 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 the subject at increased risk for secondary deterioration when assessed prior to infusion
- Has hypotension as defined as the need for intravenous pressor support of systolic blood pressure < 90 mm Hg
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 |
|---|---|---|
| HPC, Cord BloodAlso: Allogeneic umbilical cord blood, hematopoietic stem cellsHPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters. The exact precryopreservation nucleated cell content is provided on the container label and accompanying records. | Biological | HPC, Cord Blood |
Primary outcome
Adverse Events
Time frame: 12 months post first administration
Number of subjects experiencing any study related Adverse Event (AE) (including clinical laboratory tests, vital signs, 12-lead electrocardiogram (ECG), and physical examination findings) during the 12-month follow-up period
Graft Versus Host Disease
Time frame: 12 months post first administration
Number of subjects experiencing Graft Versus Host Disease (GVHD) at 12-month follow-up period
12 secondary outcomes
Change in National Institutes of Health Stroke Scale
Time frame: 3 months post first administration
Change in National Institutes of Health Stroke Scale
Time frame: 6 months post first administration
Change in National Institutes of Health Stroke Scale
Time frame: 12 months post first administration
Change in modified Rankin Score
Time frame: 3 months post first administration
Change in modified Rankin Score
Time frame: 6 months post first administration
Change in modified Rankin Score
Time frame: 12 months post first administration
Change in Barthel Index
Time frame: 3 months post first administration
Change in Barthel Index
Time frame: 6 months post first administration
Change in Barthel Index
Time frame: 12 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Time frame: 3 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Time frame: 6 months post first administration
Change in Infarct Volumes measured by Magnetic Resonance Imaging
Time frame: 12 months post first administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- 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.
Brian Mehling, MD principal investigator
BHI Therapeutic Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HPC, Cord Blood in people with Acute Ischemic Stroke, run by BHI Therapeutic Sciences at 1 site 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 10 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Mehling, MD (2013427662, mmanvelyan@bluehorizoninternational.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 12 months post first administration). 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?
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 1 Dec 2020.