Studies conducted in different countries have corroborated that a certain number of patients recovered from COVID-19, mainly those who reached serious condition requiring admission to intensive care units, presenting some type of long-term effect, particularly lung lesions.
Taking into account reports issued on the subject by prestigious international scientific centers, Cuba has also been paying special attention to the medical follow-up of discharged patients, with the aim of detecting in time any damage to the lungs, and preventing its progression toward irreversible respiratory insufficiency.
Among such efforts is the novel clinical trial recently begun at the National Institute of Haematology and Immunology (IHI) of the Ministry of Public Health (Minsap), under the direction of Dr. Consuelo Macías Abraham, director of the institution, who responded to Granma’s questionnaire as follows:
- What is the nature of the clinical trial being conducted at IHI?
It consists of using adult stem cells in the COVID-19 convalescent patient with proven lung lesions. We have been able to include in the study patients who were in serious or critical condition during their hospitalization, presenting acute respiratory symptoms. In these patients, the presence of inflammatory or fibrotic lesions, as long term consequences of infection by the new coronavirus, were detected by means of the high resolution Computerized Axial Tomography (CAT).
The patient is visited at home to explain what the investigation is about. Once consent has been obtained, the patient is transferred to the IHI, where they undergo a comprehensive clinical and laboratory evaluation, including functional respiratory tests.
Then the patient is sent to the National Institute of Oncology and Radiobiology (NIOR) to perform the CAT to look for any injury.
After a comprehensive evaluation of the case by a multidisciplinary team including immunologists, pulmonologists and imaging specialists, the decision is made to apply stem cell treatment.
- What type of stem cells are used?
When the patient is included in the study, treatment begins by injecting Granulocyte Colony Stimulating Factor, Leukocim, a product manufactured at the Center for Molecular Immunology, to achieve the mobilization of stem cells from the bone marrow to peripheral blood.
This product has proven safety and efficacy in its use, with the same purpose, for haematopoietic transplantation. Subsequently, the patient’s blood is extracted, and the mononuclear cells are separated and concentrated.
Within this cell pool there are haematopoietic stem cells and other non-haematopoietic cells, also from the medullary stromal, which include so-called mesenchymal cells and other very small cells called VSELS, which have immunoregulatory properties and promote the disappearance of lesions and the reconstitution of lung tissue.
The cells are infused intravenously. We evaluate the patient after one month and then again after six months to determine the clinical efficacy of this cell therapy.
- What results do you hope to obtain with the treatment?
The purpose is to eliminate or diminish the interstitial inflammatory or fibrotic lung lesions left by the infection and prevent the progression of the disease, thereby improving quality of life. This treatment will benefit all Cuban patients who were in serious or critical condition with proven pulmonary lesions. We have already treated patients from Havana and have begun to receive patients from other provinces.
- What would be the significance of this contribution for the country’s Public Health?
Without a doubt, it would represent a new achievement of Cuban science, as it would allow for the extension of this treatment to other chronic lung diseases, such as Chronic Obstructive Disease and Idiopathic Fibrosis, among others.
Plus, it would open new horizons in the application of cell therapy in Cuba.
- Can you explain what the term Regenerative Medicine means and when did its development begin in our country?
Regenerative Medicine is a biological discipline, which replaces or regenerates cells, tissues, or organs with the purpose of restoring or establishing normal function. It is developed through cell therapy, bioactive soluble factors, gene transplantation and tissue engineering.
Its development began in 2004, when a working group led by Dr. Porfirio Hernández Ramírez, was conducted at the Institute of Haematology and Immunology. Subsequently, it was extended to several hospitals in the country and specialties for the treatment of various chronic non-communicable diseases, to improve the quality of life of patients with few therapeutic options”.
- Has cell therapy been used in the world against infection caused by the SARS-COV-2 virus?
In China, during the epidemic, several patients were treated with cells obtained from the umbilical cord, and scientific evidence of the improvement of a gravely ill patient, who was treated with mesenchymal stem cells, has been disclosed.
Other countries have reported their use, though not yet published in scientific journals. This therapeutic approach is based on the growing number of clinical trials based on the use of mesenchymal cells in lung diseases.
Through December 2019, almost 60% of clinical trials in lung diseases were conducted with mesenchymal stem cells, obtained from bone marrow, and the remaining 40% with perinatal stem cells, according to international statistical data.
I must emphasize that in the case of Cuba, the trial marks the beginning of care for recovered patients in the national health system, including the primary level, with a first level comprehensive study and the possibility of consultations with other specialties.
Likewise, the infrastructure and organization of the Ministry of Public Health makes possible applied research of technological innovations, such as the one we are conducting on the use of adult stem cells”.
(Source: Granma)