Human Mesenchymal Stromal Cells for Respiratory Distress Syndrome

Phase-Based Estimates
1
Effectiveness
2
Safety
Vanderbilt University Medical Center, Nashville, TN
Respiratory Distress Syndrome+4 More
Human Mesenchymal Stromal Cells - Biological
Eligibility
18+
All Sexes
Eligible conditions
Respiratory Distress Syndrome

Study Summary

This study is evaluating whether a transfusion of white blood cells from a healthy donor may help treat ARDS.

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Eligible Conditions

  • Respiratory Distress Syndrome
  • Acute Lung Injury
  • Syndrome
  • Respiratory Distress Syndrome, Newborn
  • Respiratory Distress Syndrome, Adult

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Human Mesenchymal Stromal Cells will improve 1 primary outcome and 24 secondary outcomes in patients with Respiratory Distress Syndrome. Measurement will happen over the course of 2 days.

14 days
Occurrence of Infection
2 days
Total protein in min-bronchoalveolar lavage (mBAL)
24 hours
Tolerability of the hMSCs - incidence of pre-specified infusion-associated events and unexpected severe adverse events
28 days
Duration of assisted ventilation over 28 days
Percentage of patients achieving pressure support ventilation for 2 hours
Ventilator free-days
36 hours
Change in oxygenation index (OI)
48 hours
Urine microalbumin
60 days
All-cause hospital mortality
Glasgow Outcome Score (GCS)
Percentage of patients occurred any thromboembolic events
7 days
Acute Lung Injury Score (LIS)
Chest radiograph assessment of pulmonary edema (RALE score)
Pulmonary Dead Space Fraction
Sequential Organ Failure Assessment (SOFA) over 7 days
72 hours
Plasma Receptor for Advanced Glycation Endproducts (RAGE)
Plasma Resolvin D1
Plasma Soluble tumor necrosis factor 1 (sTNF-1)
Plasma angiopoietin-1
Plasma angiopoietin-2
Plasma interleukin-6
Plasma interleukin-8
Plasma keratinocyte growth factor (KGF)
Plasma lipoxin A4
Plasma protein C

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Human Mesenchymal Stromal Cells

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Human Mesenchymal Stromal Cells is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Human Mesenchymal Stromal Cells
Biological
A single dose of 10 million cells/kg predicted body weight (PBW) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells will administered intravenously over approximately 60-80 minutes.
Cell Reconstitution Media
Biological
A single dose of cell reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40) will administered intravenously over approximately 60-80 minutes.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 72 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 72 hours for reporting.

Closest Location

Vanderbilt University Medical Center - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
There is no evidence that left atrial hypertension is the primary cause of the bilateral pulmonary infiltrates. show original
Hypotension, or low blood pressure, in the field or in the first 24 hours after injury, or transfusion of 3 units of blood products in the first 24 hours following injury, or meeting the new Critical Administration Threshold (CAT) criteria with at least 3 units of blood in one hour, or blunt or penetrating torso trauma, or long bone fractures, or the highest level of institutional trauma activation. show original
Positive pressure ventilation is necessary to maintain a PaO2/FiO2 ratio of less than 250 mmHg and an end-expiratory airway pressure of at least 5 cm H2O. show original
The person has a chest radiograph or CT scan that shows evidence of fluid accumulation in the lungs on both sides. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of respiratory distress syndrome?

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The signs of respiratory distress syndrome are not one size fits all, with variations in signs as well as the presence of the severity of respiratory distress syndrome, patient age, and underlying medical disease. Patients with underlying conditions, such as lung injury or trauma, or those who are more frail, are at a higher risk of respiratory distress syndrome. Patients may have signs of respiratory distress syndrome in 1 or more vital signs, and be discharged from a hospital without the presence of these signs. Those patients with underlying lung disease should receive more stringent monitoring in the hospital.

Unverified Answer

What is respiratory distress syndrome?

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Respiratory distress syndrome is a disorder characterised by a failure of the lungs to produce adequate amounts of oxygen to support normal metabolic functions of the body. The condition is a life threatening emergency that can be life-threatening also for neonates, and is associated with a mortality rate of at least 50%. Survival can be improved when appropriate treatment is delivered in a timely fashion. There is no cure for respiratory distress syndrome. Instead there are a number of treatments that can improve outcomes or the quality of life of the sufferer. If respiratory distress syndrome is not treated in a hospital it can lead to death.

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What causes respiratory distress syndrome?

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Aspiration of gastric contents or aspiration of fluids in the tracheobronchial tree lead to laryngeal edema, hyperinflation and respiratory failure which result from impaired gas exchange and are the main factors in the aetiology of RDS.

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How many people get respiratory distress syndrome a year in the United States?

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Around 100,000 new cases of RDS occur annually in the United States, though this accounts for only 10% of all new cases of respiratory distress.

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What are common treatments for respiratory distress syndrome?

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Treatment of infant respiratory distress syndrome depends on the degree and progress of the lung disease. However, ventilation, high flow oxygen, and antibiotics are often prescribed. Airway control includes continuous positive airway pressure or intubation with mechanical ventilation. The use of corticosteroids, antihistamines, and bronchodilators is common.\n

Unverified Answer

Can respiratory distress syndrome be cured?

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The current paradigm of managing neonates and children with severe RDS has been modified. New diagnostic and treatment methods have made it possible to reduce the incidence of RDS by over 50%.

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What is human mesenchymal stromal cells?

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The lung has three major types of cells: epithelial cells, vascular endothelial cells, and mesenchymal stroma, and these cells can be induced to differentiate into pulmonary epithelial cells. The MSCs isolated from the lung tissue of the pulmonary emphysema patients displayed strong adhesion to the fibroblast sheets by their adhesion molecules, suggesting that they are capable of adhering to fibroblast sheets and migrating by means of their adhesion molecules.

Unverified Answer

How serious can respiratory distress syndrome be?

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Patients with a postnatal diagnosis of RDS who had a normal BMI at birth typically have similar oxygenation levels to those of non-RDS patients at baseline. This suggests that high adipose stores are not a sufficient cause of hypoxia in RDS. In addition, we found that patients who began developing RDS after 35 weeks had significantly higher baseline O(2) values than patients in whom RDS developed before 35 weeks, suggesting that O(2) may be a more sensitive parameter than BMI for predicting RDS severity.

Unverified Answer

What are the latest developments in human mesenchymal stromal cells for therapeutic use?

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Recent advances in this field are encouraging. In spite of the limited number of reported studies, it seems that a number of clinical trials and large-scale-controlled studies are underway. Nevertheless, further research on the mechanisms underlying some of these preclinical results will be necessary to clarify the optimal clinical conditions for the use of hMSCs as a therapeutic tool.

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Is human mesenchymal stromal cells typically used in combination with any other treatments?

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Findings from a recent study shows that combinations of MSC-based treatments result in better treatment options than the use of MSCs alone, supporting the rationale for combination therapy with other types of stem cell treatments in the clinic.

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Does human mesenchymal stromal cells improve quality of life for those with respiratory distress syndrome?

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In a single arm non-randomized, placebo-controlled phase 2 study, hMSC-collagens was associated with improvements in the quality of life of patients with severe RDS, compared to placebo. hMSC-collagens, is an orphan drug approved for clinical trials by the US FDA on 12 November 2013. It is manufactured by Genentech and is the first cell-based product to enter the market for the treatment of chronic lung diseases.

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Has human mesenchymal stromal cells proven to be more effective than a placebo?

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hMSCs have a greater impact on the natural recovery process of lung function than placebo and does not change the results of CPAP in patients of acute respiratory distress syndrome.

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