Mesenchymal Stem Cells in Patients Diagnosed With COVID-19
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|ClinicalTrials.gov Identifier: NCT04611256|
Recruitment Status : Recruiting
First Posted : November 2, 2020
Last Update Posted : November 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Biological: MSC Drug: Control||Phase 1|
Within the epidemic context of phase 3 that currently exists in Mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. Adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues.
Patients diagnosed COVID-19 and confirmed positive with the virus by PCR, will be treated with two intravenous infusions MSCs on the day 1 (D1) and the day 3 (D3) of the treatment consisting of 1X106/kg each.
We will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25.
Days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, C reactive protein, immune cells (CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes), pro-inflammatory cytokines (IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10), immunoglobulins (IgA, IgG, IgM, and IgE), HLA profile expression, and weaning from mechanical ventilation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition|
|Actual Study Start Date :||August 1, 2020|
|Estimated Primary Completion Date :||November 30, 2020|
|Estimated Study Completion Date :||December 30, 2020|
|Experimental: MSC transfusion||
Two intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach
|Active Comparator: Control||
Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
- Change form baseline in Arterial oxygen saturation [ Time Frame: up to 25 days ]Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography
- Change form baseline in Arterial oxygen saturation [ Time Frame: up to 25 days ]Aretrial oxygen saturation will be taken by an oximeter
- Days to clinical improvement [ Time Frame: up to 25 days ]Number of days of patient discharge
- Change Form Baseline in C reactive protein at 25 days [ Time Frame: up to 25 days ]Blood samples will be taken on days 1, 3, 7, 15, 20, 25
- Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes [ Time Frame: up to 25 days ]Blood samples will be taken on days 1, 3, 7, 15, 20, 25
- Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10 [ Time Frame: up to 25 days ]Blood samples will be taken on days 1, 3, 7, 15, 20, 25
- Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE. [ Time Frame: up to 25 days ]Blood samples will be taken on days 1, 3, 7, 15, 20, 25
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04611256
|Hospital Regional Lic Adolfo Lopez Mateos||Recruiting|
|Mexico City, Ciudad De Mexico CDMX (Mexico City), Mexico, 01030|
|Contact: Martha E. Rodríguez Arellano, MD +52 5512999131 firstname.lastname@example.org|