Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome

NCT04447833 | Completed Phase 1 DMC

• 1 other identifier: 2020-02238
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.

Conditions

ARDS, Human; COVID

Keywords

Mesenchymal Stromal Stem Cells

Outcome Measures

Primary Outcomes (1)

• The incidence of pre-specified treatment related adverse events of interest (TRAEIs).

  The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion: * New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion * New cardiac arrhythmia requiring cardioversion within 10 days after infusion * Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion * Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion * Cardiac arrest or death within 10 days after infusion

  From drug administration to day 10 post-infusion

Secondary Outcomes (24)

• Safety; All-cause mortality

  60 days post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

• Changes in Leucocytes

  Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

• Changes in Trombocytes

  Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

• Changes in plasma concentration of C-reactive protein (CRP)

  Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

• Changes in plasma concentration of Prothrombin complex (PK)

  Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion

Study Arms (1)

Mesenchymal Stromal Stem Cell Treatment

EXPERIMENTAL

Infusion of allogeneic bone marrow derived mesenchymal stromal stem cells (MSC). First three patients receive a singe dose of 1x10\^6 MSC/kg dose, next six patients receive a single dose of 2x10\^6 MSC/kg.

Drug: Mesenchymal Stromal Stem Cells - KI-MSC-PL-205

Interventions

Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 DRUG

Allogeneic bone marrow derived mesenchymal stromal stem cells (MSCs).

Also known as: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells

Mesenchymal Stromal Stem Cell Treatment

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide written informed consent prior to performing study procedures (and have given written consent)
• Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening
• Male or female patient aged 18 to 65 years old
• Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
• Patient is on respirator support within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
• Pregnancy test in blood confirming negative results before enrolment (for women ≤55 years old)

You may not qualify if:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
• Patients with history of treated blood and/or solid organ malignancy with recurrence within five years prior to dosing of the ATIMP are to be excluded. Patients with history of cervix cancer and non-melanoma skin cancer with recurrence within two years prior to dosing of the ATIMP are to be excluded
• Pregnant or breast feeding female
• Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery
• Patients with a history and/ or on-going treatment for entity associated with bleeding disorder or potential risk for bleeding (e.g. inflammatory bowel disease, gastro-esophagitis with or without ulcers, haemophilia and other bleeding disorders, inflammatory musculo-skeletal disease with potential bleeding complications)
• Patients with a history during the latest five years and/or on-going treatment for systemic infection (e.g. Septicaemia due to in vivo foreign body (e.g. stents, catheters, heart valve), tuberculosis, malaria, other opportunistic and parasite infections)
• Prisoner
• Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50%
• Moderate to severe liver failure (Child-Pugh Score \>12)
• Reduced renal function with a creatinine clearance (Cockcroft-Gault Equation) \< 45 mL/min/1.73m2
• Severe chronic respiratory disease with a PaCO2 \>50 mmHg or the use of home oxygen
• Major trauma in the prior 5 days
• Lung transplant patient
• Patients on ECMO-support
• Patients with a previous history of severe burns

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Oscar Simonsson, MD, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS).

Study Record Dates

• First Submitted: June 20, 2020
• First Posted: June 25, 2020
• Study Start: June 17, 2020
• Primary Completion: January 30, 2021
• Study Completion: April 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

SE (1)