Clinical Use of Stem Cells for the Treatment of Covid-19

NCT04392778 | Completed Phase 1 DMC

• 1 other identifier: Bak. Sadi Konuk-Istinye Uni.
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to use the regenerative and repair abilities of stem cells to fight against the harmful effects of the novel coronavirus Covid-19 and therefore develop a treatment strategy. It is known that fatalities from this virus is largely caused by its damage to lungs and other organs. As the disease progresses, these organs fail and lead to mortality. Our hope is that the stem cell transplantation from healthy donors will repair the damage caused by the virus and result in a healthy recovery.

Conditions

Covid19; Pneumonia; Multiple Organ Failure; Corona Virus Infection

Keywords

Covid-19; Pneumonia; Multiple Organ Failure; Coronavirus; Mesenchymal stem cells; Cellular therapy

Outcome Measures

Primary Outcomes (1)

• Clinical improvement

  Improvement of clinical symptoms related to Covid-19 infection (fever, pneumonia, shortness of breath)

  3 months

Secondary Outcomes (3)

• Lung damage improvement

  3 months

• Sars-Cov-2 viral infection laboratory test

  3 months

• Blood test

  3 months

Study Arms (3)

Untreated

NO INTERVENTION

Group 1: patients that are not on a ventilator (n=10) No extra intervention will be done.

Saline Control

SHAM COMPARATOR

Group 2: patients that are on a ventilator and will receive saline injections (n=10) as control for MSC transplantation group (3).

Biological: Saline Control

Experimental UC-MSCs

EXPERIMENTAL

Group 3: patients that are on a ventilator and will receive MSC transplantation injections (n=10)

Biological: MSC Treatment

Interventions

MSC Treatment BIOLOGICAL

Protocol length: 1 week Doses: 1. Application: 3 million cells/kg IV-------------------------------------------------0 day 2. Application: 3 million cells/kg IV ------------------------------------------------3rd day 3. Application: 3 million cells/kg IV -------------------------------------------------6th day will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.

Experimental UC-MSCs

Saline Control BIOLOGICAL

Saline will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.

Saline Control

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old male or female
• Confirmed 2019-nCoV infection with RT-PCR Laboratory test
• Confirmed Pneumonia with chest radiography and computer tomography
• and any of the following criteria:
• Shortness of breath (RR ≥30/min)
• Resting finger oxygen saturation 93%
• Arterial oxygen partial pressure (PaO2)/oxygen absorption concentration (FiO2) ≤ 300MMHG
• Advancing of focus in Pulmonary imaging to \>50% in 24-48 hours

You may not qualify if:

• Those who are not pregnant, breastfeeding and pregnant but who do not take effective contraceptive measures;
• Patients with malignant tumors, other serious systemic diseases and psychosis;
• Informed consent is not given or does not comply with the test requirements.
• Co-infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
• Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or co-infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus.
• Obstructive HABP / VABP caused by lung cancer or other known causes; Long-term history of use of immunosuppressive agents;
• History of epilepsy and need for continuous anticonvulsant therapy or anticonvulsant therapy taken within 3 years;
• Invasive ventilation
• Shock
• Other organ failures

Sponsors & Collaborators

• SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi: lead
• Istinye University: collaborator
• Regenerative Medicine and Stem Cell Production Center Liv MedCell: collaborator
• Liv Hospital (Ulus): collaborator

Study Sites (2)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

Istanbul, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19; Pneumonia; Multiple Organ Failure; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gokhan T Adas, Prof.Dr.

  SBÜ Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

• Erdal Karaoz, Prof.Dr.

  Istinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: May 19, 2020
• Study Start: April 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 30, 2020
• Last Updated: May 25, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)