Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02215811

Enrollment

Registered

2014-08-13

Start date

2014-03-31

Completion date

Unknown

Last updated

2014-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Adult

Keywords

Extracorporeal membrane oxygenation

Brief summary

This is a multi-center, open-label, non-randomized controlled trial. Patients with viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be performed postoperatively. All available data will be collected prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Interventions

BIOLOGICALMesenchymal stromal cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥ 18 years of age * Viral-induced acute respiratory distress syndrome * Ventilator treatment * Extracorporeal membrane oxygenation treatment * Relatives provide written informed consent

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
In-hospital mortality	During hospital stay, an expected average 2 months

Secondary

Measure	Time frame	Description
Pulmonary compliance	During ventilator treatment, an expected average of 1 month	—
Pulmonary tidal volume	During ventilator treatment, an expected average of 1 month	—
All-cause mortality	12 months	—
Recovery of organ functions	12 months	kidney, liver, heart functions
Adverse events	6 months	I.e infection, fever, effect on end-organ function

Other

Measure	Time frame	Description
Immune modulation	3 months	Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype

Countries

Sweden

Contacts

Primary ContactKarl-Henrik Grinnemo, MD, PhD

karl-henrik.grinnemo@karolinska.se+46 70 886 89 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026