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Magnum2on May 04, 2020 11:44am
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RE:Where are they at?
RE:Where are they at?Lattice Biologics Ltd. Announces Initial Recruitment of Patients for a Phase 1 Clinical Trial to Access Safety and Efficacy of AmnioBoost for Treatment of COVID-19
BELGRADE, Mont.--(BUSINESS WIRE)--March 17, 2020--Lattice Biologics Ltd. (TSX-V: LBL) (OTCBB: LBLTF) (“Lattice Biologics” or the “Company”) announces it has begun enrolling patients in its Phase 1 clinical trial to address safety and efficacy of its novel stem cell technology, AmnioBoost, for the treatment of severe acute respiratory syndrome (SARS) related to COVID-19 infection.
AmnioBoost is derived from amniotic fluid taken from non-related, healthy, living donors during a Caesarian delivery. The baby is not harmed in any way.
To be eligible for the U.S. trial, individuals must have laboratory confirmed infection with COVID-19 and evidence of lung involvement requiring supplemental oxygen or mechanical ventilation. The study will not enroll individuals with mild symptoms or individuals who are asymptomatic.
All potential patients will undergo a physical exam, participants will then be randomized into the investigational group or the placebo group. Individuals enrolled into the investigational group will receive ~ 5 million stem cells of AmnioBoost on the first day of enrollment and will receive another ~ 5 million stem cells on the second day of enrollment.
Clinicians will monitor the patients’ temperature, blood pressure, need for supplemental oxygen, and other factors daily to determine daily scores based on a scale of clinical outcomes.
In the initial stage of investigation, the clinicians will compare participant outcomes on day seven in both groups to assess if AmnioBoost treatment has produced any clinical benefit.
The study will be halted if there is no evidence of a treatment difference between AmnioBoost and placebo.
Initial patient enrollment in the trial will be limited to 10 patients and conducted in the Seattle area, as it is one of the most concentrated areas of COVID -19 infection in the United States.
“We thank the patients in advance for their participation in this cost free to the patient trial. We look forward to using a novel technology in the treatment of this highly infectious disease and to make sure the trial is carried out in the most effective manner possible,” said Guy Cook, CEO of Lattice Biologics Ltd.