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

NCT03735277 | Unknown Phase 1 FDA Drug

• 1 other identifier: BHI17-IS-A
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acute Ischemic Stroke

Keywords

Human Umbilical Cord Blood; Hematopoietic stem cells

Outcome Measures

Primary Outcomes (2)

• 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

  12 months post first administration

• Graft Versus Host Disease

  Number of subjects experiencing Graft Versus Host Disease (GVHD) at 12-month follow-up period

  12 months post first administration

Secondary Outcomes (12)

• Change in National Institutes of Health Stroke Scale

  3 months post first administration

• Change in National Institutes of Health Stroke Scale

  6 months post first administration

• Change in National Institutes of Health Stroke Scale

  12 months post first administration

• Change in modified Rankin Score

  3 months post first administration

• Change in modified Rankin Score

  6 months post first administration

Study Arms (1)

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.

Biological: HPC, Cord Blood

Interventions

HPC, Cord Blood BIOLOGICAL

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.

Also known as: Allogeneic umbilical cord blood, hematopoietic stem cells

HPC, Cord Blood

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BHI Therapeutic Sciences: lead

Study Sites (1)

BHI Therapeutic Sciences

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Brian Mehling, MD

  BHI Therapeutic Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Mehling, MD

CONTACT

2013427662; mmanvelyan@bluehorizoninternational.com

Marina Manvelyan, PhD

CONTACT

2013427662; mmanvelyan@bluehorizoninternational.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 8, 2018
• Study Start: March 6, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 1, 2020

Record last verified: 2020-11

Locations

US (1)