Evaluation of the Safety and Efficacy of Hemacord HPC, Cord Blood in Subjects With Acute Ischemic Stroke

Status unconfirmed · Phase 1

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT03735277

Run by

BHI Therapeutic Sciences

People needed

10

Starts

2021-03-06

Expected to finish

2022-07-01

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• BHI Therapeutic Sciences — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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