Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure (STELLAR)

Asan Medical Center

Status and phase: Unknown; Phase 2

Conditions: Respiratory Distress Syndrome, Adult

Treatments: Biological: Mesenchymal Stem Cell

Study type: Interventional

Funder types: Other

Identifiers

NCT02112500

STELLAR-Pilot

Details and patient eligibility

About

Although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still high and the life quality is frequently compromised from pulmonary fibrosis.

The investigators hypothesize that the treatment using mesenchymal stem cell can be beneficial in patients with respiratory failure. The present study is a pilot study evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with respiratory failure.

Full description

Although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still reported to be more than 40%. The respiratory distress syndrome may develop in all ages resulting in progressive pulmonary fibrosis. A number of survivors from respiratory failure suffer from the sequelas of pulmonary fibrosis.

However, the treatments of respiratory failure are limited to the correction of baseline disease, cardiopulmonary support, and conservative management to minimize the lung injury. There has not been any effective and specific treatment for respirator distress nor medicine to reduce mortality.

There have been reports of mesenchymal stem cell experimental animals with chronic obstructive pulmonary disease, interstitial lung disease, and sepsis. In addition, the mesenchymal stem cell treatment showed beneficial effect in bleomycin endotoxin induced lung injury.

Authors hypothesize that the mesenchymal stem cell treatment in patients with respiratory failure will show efficacy. We would conduct the present pilot study to evaluate the efficacy and safety in patients with respiratory failure and intend to suggest an additional alternative treatment option for those without additional treatment option.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ventilator care from respiratory failure

• Ventilator care for 7 or more days

• at least one of the followings

  1. PaO2/FiO2 = 200 or less when PEEP 5 cmH2O or more.

  2. PaCO2 = 50 mmHg or more when plateau pressure of 30 cmH2O or more.

  3. pH = 7.25 or less when plateau pressure of 30 cmH2O or more.

  4. No other treatment option except for lung transplantation and not candidate for recipient (organ failure, comorbid infection, economy,...)

  5. Ventilatory care with weaning failure 3 times or more

  6. Ventilator care requiring 7 days or more from the first self respiration to weaning of ventilator.

     • PEEP, positive endexpiratory pressure

Exclusion criteria

• Severe aplastic anemia
• Malignant hematologic disorder or history of stem cell treatment.
• Currently uncontrolled malignancy or history of solid cancer within 2 years
• HIV Infection
• Expected life < 3 months from other cause than the respiratory failure
• Pregnancy or breast feeding
• Expected hypersensitivity for study drug

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Mesenchymal Stem Cell Infusion

Experimental group

Description:

Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.

Treatment:

Biological: Mesenchymal Stem Cell