HEMERA 1 CarboxyHEMoglobin OxygEn delivery for Revascularization in Acute Stroke: Phase 1 Clinical T

Introduction: A polyethylene glycol hemoglobin-based oxygen carrier (HBOC) in the carboxy state (PP-007) has shown to increases blood flow in leptomeningeal anastomosis and decrease final infarct volume in rat models of middle cerebral artery occlusion. PP-007 may deliver more oxygen than Hb contained in RBCs.

Method(s): HEMERA 1 CarboxyHEMoglobin OxygEn delivery for Revascularization in Acute Stroke (ClinicalTrials.gov NCT04677777) is a phase 1 safety clinical trial of PP-007 in patients with acute ischemic stroke with anterior circulation LVO treated with MT up to 24 hours after symptom onset. Inclusion criteria are patients with intracranial ICA and/or MCA-M1 or M2 occlusion, baseline NIHSS ≥6, baseline ASPECTS score ≥5 on NCCT, and/or core volumes <70 mL + mismatch > 50 mL on CT.

Result(s): As planned, 16 patients were enrolled. Mean age for all patients was 74.8 (STD ± 12.7), ASPECT score = 7.9 (±1.8), NIHSS at baseline = 17.3 (± 4.2), TICI 2b or c in 10, TICI 3 in 4. Fourteen patients were randomized PP-007 plus MT, 4 patients were randomized to MT only.

Conclusion(s): HEMERA 1 has completed enrollment. No safety concerns were identified so far.

Publication History

Article published online:
09 February 2023