Mesenchymal Stem Cells in Patients Diagnosed With COVID-19
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|ClinicalTrials.gov Identifier: NCT04611256|
Recruitment Status : Unknown
Verified November 2020 by M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos.
Recruitment status was: Recruiting
First Posted : November 2, 2020
Last Update Posted : November 12, 2020
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|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
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Aged between 18 and 65.
- RT-PCR positive for SARS-CoV-2 (Berlin protocol).
- Moderate to severe acute respiratory insufficiency (100 mmHg <PaO2/FiO2 ≤ 200 mmHg).
- Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography.
- Being under standard therapy for COVID-19.
- Informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation).
- Reserved prognosis (survival expected by the physician of fewer than three days).
- Being under immunosuppressive drug treatment.
- Severe kidney failure (estimated glomerular filtration rate < 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
- Immunosuppressed patients (except when the cause is corticosteroid treatment).
- Pregnant or lactating women.
- Patients who plan to become pregnant during the study period or within six months after the end of the study period.
- Participation in another clinical trial with an experimental drug during the last 30 days.
- Pathologies that in medical judgment constitute a contraindication to participate in the study.
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|
|Responsible Party:||M. Eunice Rodríguez Arellano, MD, Hospital Reg. Lic. Adolfo Lopez Mateos|
|Other Study ID Numbers:||
|First Posted:||November 2, 2020 Key Record Dates|
|Last Update Posted:||November 12, 2020|
|Last Verified:||November 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
mesenchymal stem cells
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases