Mesenchymal Stem Cells in Patients Diagnosed With COVID-19

• ClinicalTrials.gov Identifier: NCT04611256
• Recruitment Status: Unknown
• First Posted: November 2, 2020
• Last Update Posted: November 12, 2020
• Sponsor: Hospital Reg. Lic. Adolfo Lopez Mateos
• Collaborator: Instituto de Terapia Celular: ITC
• Information provided by (Responsible Party): M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos

Tracking Information

• First Submitted Date: October 29, 2020
• First Posted Date: November 2, 2020
• Last Update Posted Date: November 12, 2020
• Actual Study Start Date: August 1, 2020
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 29, 2020)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 29, 2020)

• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mesenchymal Stem Cells in Patients Diagnosed With COVID-19
• Official Title: Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition
• Brief Summary: The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.

Detailed Description

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
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

• Biological: MSC
  Two intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach
• Drug: Control
  Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.

Study Arms

• Experimental: MSC transfusion
  Intervention: Biological: MSC
• Active Comparator: Control
  Intervention: Drug: Control

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 29, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 30, 2020
• Estimated Primary Completion Date: November 30, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Mexico

Administrative Information

• NCT Number: NCT04611256
• Other Study ID Numbers: 060I.2020
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Reg. Lic. Adolfo Lopez Mateos
• Original Study Sponsor: Same as current
• Collaborators: Instituto de Terapia Celular: ITC
• Investigators: Not Provided
• PRS Account: Hospital Reg. Lic. Adolfo Lopez Mateos
• Verification Date: November 2020