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. 2022 Feb 17;13:743926. doi: 10.3389/fphar.2022.743926

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)