Treatment of Severe Acute Respiratory Distress Syndrome W... | NCT02215811

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

NCT02215811

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Aug 13, 2014Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Acute Respiratory Distress Syndrome, Adult

Interventions

Mesenchymal stromal cells

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Apr 11, 2014

First Submission Date that Met QC Criteria

Aug 12, 2014

First Posted Date

Aug 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2014

Last Update Posted Date

Aug 13, 2014Estimated

Name	Class
Karolinska Institutet	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mesenchymal stromal cells	Experimental		Biological: Mesenchymal stromal cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal stromal cells	Biological		Mesenchymal stromal cells

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary compliance		During ventilator treatment, an expected average of 1 month
Pulmonary tidal volume		During ventilator treatment, an expected average of 1 month

Other Outcomes

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karl-Henrik Grinnemo, MD, PhD	Contact	+46 70 886 89 68		karl-henrik.grinnemo@karolinska.se

Overall Officials

Name	Affiliation	Role
Karl-Henrik Grinnemo	Karolinska Institutet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital	Recruiting	Stockholm			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided