TABLE 1.
Clinical trials of rhEPO treatment for ischemic stroke patients.
| Trails | Patients | Number | Drug | Dose | Route | Time of treatment | Time of evaluation | Observations | Results | References |
|---|---|---|---|---|---|---|---|---|---|---|
| An exploratory double-blind study | Chronic stroke Patients (3 months after onset) | In a pilot study (n = 3); in an exploratory double-blind study (n = 6) | rhEPO + recombinant human G-CSF | rhEPO (300 U/kg); G-CSF (10 μg/kg) | Subcutaneous | Once a day for 5 days per month over 3 months | 0, 5, and 30 days in each cycle and on day 180 | Vital signs, adverse events, hematological values, and functional outcomes | No observations of serious adverse events. The grip power of the dominant hand was increased; mini-mental status examination (MMSE) and modified Barthel index (MBI) were not improved | Shin and Cho (2016) |
| A prospective, randomized, placebo-controlled trial (ISRCTN71371114) | Acute ischemic stroke who were not candidates for rtPA therapy at a single facility | EPO-treated group (n = 71); placebo-control group (n = 71) | rhEPO | 5000 IU/dose | Subcutaneous | 48 and 72 h after stroke | 90 days | Recurrent stroke or death; long-term functional recovery (that is, 5 years) | Did not affect long-term recurrent stroke and mortality but reduced the scale of Barthel index; EPO therapy significantly improved long-term neurological outcomes | Tsai et al. (2015) |
| A randomized clinical trial | First acute ischemic stroke within 24 h of symptom onset | EPO-treated group (n = 37); placebo-control group (n = 43) | rhEPO | 16,000 IU as a bolus dose and continued as 8000 IU each 12 h up to a total dose of 56,000 IU during 3 days | Iv | 3 days after stroke | 14 and 28 d | NIHSS | High dose of erythropoietin in first 24 h can be effective on reduction of ischemic stroke complication | Asadi et al. (2013) |
| Subgroup analysis from the data of the German Multicenter EPO Stroke Trial (Phase II/III; ClinicalTrials.gov Identifier: NCT00604630) | Acute ischemic stroke | n = 163 | rhEPO; rtPA | 40,000 IU each | Iv | Within 6 h of symptom onset, and at 24 and 48 h after stroke | 1, 2, 3, 4 and 7 days | Serum biomarker profiles (S100b, GFAP, and ubiquitin C-terminal hydrolase (UCH-L1)) | The reduction of serum biomarkers corroborated an advantageous effect of EPO in ischemic stroke | Ehrenreich et al. (2011) |
| Double-blind, placebo-controlled, randomized German Multicenter EPO Stroke Trial (Phase II/III; ClinicalTrials.gov Identifier: NCT00604630) | Acute ischemic stroke in the middle cerebral artery territory | n = 460 | rhEPO; rtPA | 40,000 IU each | Iv | Within 6 h of symptom onset, at 24 and 48 h after stroke | 90 days | Primary outcome: Barthel Index | The treatment of rtPA and rhEPO did not show any improvement in clinical outcomes but had a higher overall death rate | Ehrenreich et al. (2009) |