Why AmnioBoost?

AmnioBoost has potential for use in the treatment of ARDS, which is the principal cause of death in COVID-19 infection. Mortality in COVID-19 infected patients with the inflammatory lung condition (ARDS) is reported to approach 50%, and is associated with older age, comorbidities such as diabetes, higher disease severity, and elevated markers of inflammation. Current therapeutic interventions do not appear to improve in-hospital survival.

AmnioBoost is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. Major anti-inflammatory cytokines found in AmnioBoost include: interleukin (IL)-1beta, IL-1ra, TNF-alpha, IL-6, IL-8, IL-16, CCL2, CXCL7, MIF, and GRO a/b/g. Specific cytokine receptors for IL-1, and tumor necrosis factor-alpha, function as proinflammatory cytokine inhibitors. This is supported by recently published results from an investigator-initiated clinical study conducted in China which reported that allogeneic mesenchymal stem cells (MSCs) cured or significantly improved functional outcomes in all seven treated patients with severe COVID-19 pneumonia

AmnioBoost was originally developed for chronic adult inflammatory conditions such as osteoarthritis, but has found multiple uses in the treatment of bone and cartilage repair, as well as soft tissue repair. It is an investigational therapy comprising concentrated allogeneic MSCs and cytokines derived from amniotic fluid. The amniotic fluid is donated from non-related, healthy mothers and recovered by caesarian section; the baby is not harmed in any way. Additionally, AmnioBoost has been injected in over 1,000 patients with no adverse events, and appears to be well tolerated.

Candidate requirements 

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.

What the trial entails

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. 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.

How to enroll

To enroll in our clinical study or for more information please contact us at +1(406)570-2658 or News@LatticeBiologics.com 

 

References
1. Liu Y et al. Clinical features and progression of acute respiratory distress syndrome in coronavirus disease 2019. Medrxiv 2020; https://doi.org/10.1101/2020.02.17.20024166
2. Leng Z, et al. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia[J]. Aging and Disease, 10.14336/AD.2020.0228