Clinical trials with stem cells to treat effects of COVID-19 in the lungs advance
Dr. Odalis María de la Guardia Peña, an expert immunologist, describes as “encouraging” preliminary findings obtained at the conclusion of the first phase of clinical trials evaluating the use of stem cells in patients facing lung damage caused by COVID-19

Author: Walkiria Juanes Sánchez | internet@granma.cu
october 8, 2020 12:10:54

Photo composition: Claudia García Martínez
Dr. Odalis María de la Guardia Peña, an expert immunologist, describes as “encouraging” preliminary findings obtained at the conclusion of the first phase of clinical trials evaluating the use of stem cells in patients facing lung damage caused by COVID-19.

The study, begun during the month of May at the Cuban Institute of Hematology and Immunology (IHI), was undertaken with a view toward eliminating or reducing interstitial inflammatory or fibrotic lung lesions following the infection.

The doctor, also an infectious disease specialist and head of External Services at the IHI, explains that the research will have significant impact “if, as we hope, stem cell therapy produces positive results in these patients with pulmonary alterations post-COVID-19.

“If the treatment is effective, it will be generalized across the entire country, improving the quality of life and respiratory capacity of these patients,” she stated with the enthusiasm of someone devoted to the most important mission in the world: saving lives.

THE LUNG, THE “TARGET” ORGAN

De la Guardia Peña commented that, although SARS-COV-2 has a variety of dissimilar effects (cardiovascular, renal, cerebral, vascular, in distal or lower limbs, and others); the “target” organ in the case of COVID-19 is the lung, in which patients experience the most serious impact, both during the disease and once they have recovered, a pattern being studied internationally.

“We have detected cases, specifically in Cuban patients, who have presented this kind of affectation, especially those who have suffered symptoms over a longer period. Among those visited for the study, there were cases of important pulmonary alterations, which is the most frequent, but perhaps not the most serious,” the specialist continued.

RECRUITMENT OF VOLUNTEERS

“These recruitment consultations were atypical, as they were done in the field, visiting the homes of recovered patients,” the doctor explained, adding that potential volunteers needed to meet several criteria for inclusion in the clinical trials.

Those selected were between 18 and 70 years of age, of both sexes, who had contracted COVID-19 thirty days prior to the trial treatment, testing negative on a PCR at the time of recruitment, and exhibited respiratory symptoms since the beginning of the disease.

Specifically sought for the trials were patients who experienced a more torpid evolution of the disease, those who were hospitalized for more than 20 days, requiring oxygen, assisted ventilation, or the use of some aerosol as treatment, upon reaching serious or critical condition.

“More than 130 homes were visited over almost three months, from May to June; and 141 patients were interviewed, of which about 50 were studied. Twenty patients were included in the trial, which was the determined number,” the doctor reported.

PULMONARY SEQUELAE

“During the investigation, several long term effects of COVID-19 were noted, although the most frequent involved the lungs. In some cases, indications of pulmonary fibrosis were detected, a condition that cannot be completely corrected, and can only be treated to increase lung capacity and improve quality of life,” the doctor explained.

“The study is still in progress. The first phase has been completed, but there is some time remaining before final evaluation of the patients. What we can say is that, thus far, we are very happy with the results we have observed, they are encouraging,” she emphasized.

UNFORGETTABLE STORIES

-Could you recount some stories that particularly impacted you?

-The first day I went out to recruit volunteers, I arrived at the home of a patient who, when she opened the door, exhibited obvious difficulty breathing, evident in plain sight.

We conducted the interview and learned that she experienced this difficulty on a daily basis, five weeks after being diagnosed with COVID-19 and 15 days after a negative PCR test.

This case was significant because we became aware of the lingering effects some patients face, who after having the disease, being discharged and completing all treatment, can have symptoms for a long time.

On another occasion, a patient received us effusively, grateful that he would continue to be treated, that he would receive some follow-up. This attitude was very common in many cases, confirming for us that the patients we visited were still feeling unwell, despite having recovered and been discharged from the hospital.

YOU CAN BE ASYMPTOMATIC OR YOU CAN DIE

“You can be infected and be asymptomatic, or develop the most severe symptoms of the disease and die. This is random, no one understands or can control it,” the specialist warns, emphasizing the importance of being fully conscious of taking care of ourselves, since anyone can develop an aggressive case of COVID-19.

“I agree with everything Professor Durán says every day at nine o’clock in the morning, about how measures must be maintained and complied with: the use of facemasks, hand washing, shoe disinfection (with doormats soaked in 0.5% hypochlorite at the entrance to common areas), social distancing, and collective discipline.

“The population must take care; success in containing the pandemic lies in individual responsibility,” she concluded.

STEM CELL TREATMENT

-When the patient is included in the study, treatment begins by injecting the granulocyte colony stimulating factor, Ior Leukocim, a product manufactured at Cuba’s Center for Molecular Immunology, to achieve the mobilization of stem cells from the bone marrow to the bloodstream.

-Subsequently, the patient’s blood is extracted and mononuclear cells are separated and concentrated.

-This pool of cells includes hematopoietic and non-hematopoietic stem cells, which have immune-regulatory properties and promote the disappearance of lesions and the reconstitution of lung tissue.

-The cells are infused intravenously.

-The patient is evaluated one month following treatment and again at six months, to determine the clinical efficacy of the stem cell therapy.

Source: Granma interview with Consuelo Macías Abraham, director of the National Institute of Hematology and Immunology.