A Phase I clinical trial based on the treatment of lung injury with autologous stem cells (derived from the patient's own blood) in COVID-19 patients with lung injury demonstrated the safety and efficacy of this therapy in the indication studied.
In the context of the recent Hematology Congress 2023, Dr. Consuelo Macías Abraham, second degree specialist in Immunology and head of the National Immunology Group, said that, as a result of the trial initiated in 2020, it was concluded that autologous stem cell therapy is safe, as there were no adverse reactions in the patients who received it.
On the other hand, treatment with steroids (applied in one of the control groups of the trial) is less effective and is not safe, since it induces moderate and severe adverse reactions with complications in the patient's clinical condition, she stressed.
In turn, the expert stressed, autologous stem cell therapy is effective, six months after application it reduced post-COVID-19 lung injuries by more than 50% in the great majority of patients, while at the same time reducing inflammatory biomarkers and improving the patient's respiratory function.
The also President of the Scientific Council of the Institute of Hematology and Immunology (IHI), the center promoting the study, explained that this Phase I non-randomized controlled clinical trial set out to explore the therapeutic effect and safety of treatment with autologous stem cells in patients with lung lesions recovered from COVID-19.
For this purpose, the specialist added, it was specifically based on knowing and describing the safety profile of stem cell therapy in patients with lung injuries caused by cell and tissue damage caused by the complications of the viral infection, combined with the effects of mechanical ventilation; as well as evaluating the clinical effectiveness of the therapy in a small group of patients.
Macías Abraham specified that the product evaluated in the trial was autologous stem cells derived from bone marrow, mobilized to peripheral blood through stimulation with the drug ior® Leukocim, which are administered intravenously.
He also said that the criterion for response or improvement taken as a reference when the patients were treated was the evaluation of the respiratory functional study, and images of interstitial lesions or pulmonary fibrosis on high-resolution computerized axial tomography (CAT).
Dr. Macías Abraham remarked, as other results obtained from the trial, the safety and effectiveness of the product ior® Leukocim in the mobilization of stem cells to the peripheral blood; and the introduction of a new automated quantitative program for the evaluation of lung lesions by CT in Cuba.
The Immunology specialist also highlighted the fact that it was a multicenter trial, which had the outstanding participation of specialists and institutions, such as the Center of Molecular Immunology, the Center of Neurosciences of Cuba, the National Institute of Oncology and Radiobiology, and the Hospital Comandante Manuel Fajardo, among others.
