RESUMO
OBJECTIVE: Mesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodulatory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage. METHOD: Phase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed. RESULTS: No adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention. CONCLUSION: Administration of 100 million mesenchymal stem cells in combination with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry- India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175.
RESUMO
BACKGROUND: Access to reproductive health services in Human Immunodeficiency Virus (HIV) programs can greatly enhance program's potential to limit the spread of disease, reduce unintended pregnancies and safeguard the health of infected people. OBJECTIVES: To assess (i) knowledge, attitude, and use regarding contraceptives; safe sex and dual protection; (ii) fertility desires and unintended pregnancies post HIV and (iii) symptoms of reproductive tract infection/sexually transmitted infection (RTI/STI) among women infected with HIV. MATERIALS AND METHODS: A cross-sectional study among 300 currently married HIV-positive women who had not undergone permanent sterilization with no immediate desire for pregnancy. Study site was Integrated Counseling and Testing Centers (ICTC) in tertiary hospitals of Mumbai and women were interviewed using a semistructured questionnaire. RESULTS: In spite of good awareness about modern methods, 42.7 felt that contraceptives other than condoms were harmful to use due to their HIV status. Knowledge on dual protection was limited to condom (75%). Condom use increased from 5.7% pre-HIV to 71.7% post-HIV, with 89.6% reporting regular use. Future fertility desire was expressed by 8.7% women. Induced abortions post-HIV was reported by16.6% women, as pregnancies were unintended. About 69% wished to use dual contraceptive methods for effective protection if it was not harmful to be used by people living with HIV (PLHIV). CONCLUSION: Data reveals a need to promote modern contraceptive methods along with regular condom use to prevent unintended pregnancies and improve health-seeking behavior for contraception. Health system models that converge or link HIV services with other reproductive health services need to be tested to provide comprehensive reproductive healthcare to infected women in India.