Menstrual Blood Stem Cells in Severe Covid-19

NCT05019287 | Completed Phase 1 DMC

• 2 other identifiers: 990308-02699/3436
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized controlled trial (RCT), severe cases of COVID-19 infection will be treated with secretome of menstrual blood stem cells. The improvement in the clinical, laboratory and radiological manifestations will be evaluated in treated patients compared with the control group.

Conditions

Covid19; Cytokine Storm

Keywords

mesenchymal stem cells; menstrual blood stem cell; secretome; covid-19

Outcome Measures

Primary Outcomes (2)

• Adverse reactions incidence

  The proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.

  Day 0 - 28

• Time to clinical improvement

  Days from administration of the Investigational Product for improvement

  Day 0 - 28

Secondary Outcomes (8)

• Assessment of serum CRP (mg/L) levels

  Days 0, 5, 10, 14, and 28

• Assessment of serum LDH (U/L) levels

  Days 0, 5, 10, 14, and 28

• Assessment of serum Ferritin (ng/ml) levels

  Days 0, 5, 10, 14, and 28

• Assessment of serum D-dimer (microgr/ml) levels

  Days 0, 5, 10, 14, and 28

• Immunological changes on CD4+ T and CD8+ T

  Days 0, 5, 10, 14, and 28

Study Arms (2)

Menstrual blood stem cell secretome group

EXPERIMENTAL

Intravenous Allogeneic Menstrual Blood Stem Cells Secretome injection+Routine treatment

Biological: Allogeneic human menstrual blood stem cells secretome

Control group

PLACEBO COMPARATOR

Intravenous saline injection (Placebo)+Routine treatment

Other: Intravenous saline injection

Interventions

Allogeneic human menstrual blood stem cells secretome BIOLOGICAL

This COVID-19 Study intervention consists of Intravenous Allogeneic human menstrual blood stem cell (MenSC) secretome injection in addition to standard care. The MenSC were characterized as CD90+, CD73+, CD105+, and CD45-based on multiparameter flow cytometry.

Menstrual blood stem cell secretome group

Intravenous saline injection OTHER

Intravenous saline injection in addition to standard care

Control group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose clinical and laboratory test results have a positive diagnosis of Covid-19.
• Patients who are willing to participate as subjects in the study by signing the informed content.
• Diagnosed with severe pneumonia of COVID: respiratory distress, RR \>30 times/min; resting oxygen saturation of 90% or less; arterial partial pressure of oxygen / oxygen concentration ≤300mmHg; Pulmonary infiltration more than 50% in 24 to 48 hours
• SARS-CoV-2 nucleic acid test was positive.

You may not qualify if:

• History of drug reactions or allergies
• Pneumonia caused by bacteria, Mycoplasma, Chlamydia, Legionella, fungi, or other viruses
• Airway obstruction due to lung cancer or unknown factors
• Carcinoid syndrome
• History of epilepsy and long-term use of anticonvulsant drugs during the last 3 years
• History of long-term use of immunosuppressive drugs
• History of chronic respiratory illness that requires long-term oxygen therapy
• The patient is on blood or peritoneal dialysis
• Creatinine clearance \<15 ml / min
• Moderate to severe liver disease (Child-Pugh score\> 12)
• History of deep vein thrombosis (DVT) or pulmonary embolism over the past 3 years
• Being under ECMO or high-frequency oscillatory ventilation support
• Diagnostic of HIV, hepatitis B, and syphilis
• Pregnant or lactating women
• Lack of consciousness and inability to provide informed consent by the patient

Sponsors & Collaborators

• Avicenna Research Institute: lead
• Tehran University of Medical Sciences: collaborator

Study Sites (1)

Avicenna Research Institute

Tehran, Iran

Location

Related Publications (1)

• Fathi-Kazerooni M, Fattah-Ghazi S, Darzi M, Makarem J, Nasiri R, Salahshour F, Dehghan-Manshadi SA, Kazemnejad S. Safety and efficacy study of allogeneic human menstrual blood stromal cells secretome to treat severe COVID-19 patients: clinical trial phase I & II. Stem Cell Res Ther. 2022 Mar 7;13(1):96. doi: 10.1186/s13287-022-02771-w.

  PMID: 35255966 DERIVED

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Mina Fathi Kazerooni, MD, PhD

  Nanobiotechnology Research Center Avicenna Research Institute, ACECR, TEHRAN, IRAN

  PRINCIPAL INVESTIGATOR

• Ali Dehghan-Manshadi, MD

  Department of Infectious Diseases and Tropical Medicine - Iranian Research Center for HIV/AIDS,TUMS

  STUDY CHAIR

• Samrand Fattah-Ghazi, MD

  Tehran University of Medical Science (TUMS)

  STUDY DIRECTOR

• Somaieh Kazemnejad, PhD

  Nanobiotechnology Research Center Avicenna Research Institute, ACECR, TEHRAN, IRAN

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessments regarding clinical recovery will be conducted by the outcomes assessors blind to treatment allocation. Due to the nature of the intervention, staff cannot be blinded to allocation, but the participants are blind to the group to which they belong. An employee outside the research team will feed data into the computer in separate datasheets so that the outcomes assessors can analyses data without having access to information about the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Biological: allogeneic human menstrual blood stem cells secretome Intravenous injection of 5 ml menstrual blood stem cells secretome on day 1, day 2, day 3, day 4, and day 5, based on the routine treatment of COVID-19 2. Other: Intravenous saline injection (Placebo) Intravenous injection of 5ml of 0.9% saline on day 1, day 2, day 3, day 4, and day 5, based on the routine treatment of COVID-19

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: August 24, 2021
• Study Start: April 17, 2021
• Primary Completion: May 21, 2021
• Study Completion: June 9, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)