Evaluation of the Safety and Efficacy of HPC, Cord Blood

NCT03735277 Phase 1 UNKNOWN

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.

Details

Lead sponsor	BHI Therapeutic Sciences
Phase	Phase 1
Status	UNKNOWN
Enrolment	10
Start date	2021-03-06
Completion	2022-07

Conditions

• Acute Ischemic Stroke

Interventions

• HPC, Cord Blood

Primary outcomes

• Adverse Events — 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 — 12 months post first administration
  Number of subjects experiencing Graft Versus Host Disease (GVHD) at 12-month follow-up period

Countries

United States