What the trial was testing
The FRIDA enrolled 336 patients with stroke. The study was sponsored by Supergene, LLC and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
50% of patients treated with staphylokinase had good recovery, versus 40% with standard treatment.
The Lancet. Neurology · 2021 · NCT03151993
These findings — that half of stroke patients treated with staphylokinase recovered to independence at 3 months — were published in the The Lancet. Neurology and represent the headline result of the study.
Researchers tracked outcomes across 336 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with stroke, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Staphylokinase is not yet FDA-approved in the United States. This large trial in Russia showed it worked as well as the current standard clot-buster, alteplase, and may cause fewer serious side effects. If you or a loved one has a stroke, call 911 immediately — alteplase is widely available and proven to save lives when given quickly.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open stroke trials
Body Composition and Acute Stroke
Body composition appears to be a prognostic factor for the severity and functional outcome of stroke patients. In this study the prognostic value of two bioimpedance parameters will be studied (skeletal mass index and phase angle) and two temporal muscle measurements (thickness and surface area) to predict the functional outcome of patients at discharge and at 6 months
Intracerebral Autologous Stem Cell Therapy for Chronic Stroke Patients
The goal of this clinical trial is to evaluate if autologous mesenchymal stem cell (HUNS001-01) transplantation therapy can provide neurological recovery in patients with chronic stage of stroke resulting in moderate to severe neurological sequelae. The main questions it aims to answer are: Can HUNS001-01 intracerebral transplantation demonstrate improvement in the mRS of disability for 1 year after intervention? Can HUNS001-01 intracerebral transplantation can be performed without any adverse events for 1 year after intervention? Participants will receive the below interventions. * Screening for the eligibility to enroll the clinical trial (interview, blood test, imaging) * Harvest of platelet concentrates (PC) * Harvest of bone marrows (BM) * Receive intracerebral transplantation surgery of HUNS001-01 * Post-operative rehabilitation * Follow-up studies (until 1 year or termination of the trial)