Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

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Official title:

A Phase 1 Multi-center Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stem Cells for the Treatment of Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01775774
• Other study ID #: ARDS MSC 001
• Secondary ID: 1U01HL108713-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 18, 2013
• Last updated: August 14, 2014
• Start date: July 2013
• Est. completion date: February 2017

Study information

• Verified date: August 2014
• Source: University of California, San Francisco
• Contact: Michael A Matthay, MD
• Phone: 415-353-1206
• Email: michael.matthay[@]ucsf.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal GovernmentUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.

Description:

The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 69
• Est. completion date: February 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:

Acute onset (defined below) of:

1. A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)

2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph

3. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

In addition to meeting inclusion criteria, enrollment must occur within 96-hours of first meeting ARDS criteria per the Berlin definition of ARDS.

Exclusion Criteria:

1. Age less than 18 years

2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS

3. Pregnant or breast-feeding

4. Prisoner

5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years

6. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%

7. Moderate to severe liver failure (Childs-Pugh Score > 12)

8. Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen

9. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).

10. Major trauma in the prior 5 days

11. Lung transplant patient

12. No consent/inability to obtain consent

13. Moribund patient not expected to survive 24 hours

14. WHO Class III or IV pulmonary hypertension

15. Documented deep venous thrombosis or pulmonary embolism within past 3 months

16. No arterial line/no intent to place an arterial line

17. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol

18. Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Stanford University Medical Center	Stanford	California

Sponsors (6)

Lead Sponsor	Collaborator
Michael A. Matthay	Massachusetts General Hospital, National Heart, Lung, and Blood Institute (NHLBI), Stanford University, University of Minnesota - Clinical and Translational Science Institute, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of treatment adverse event rates between the 1, 5 and 10 million cells per kilogram dose cohorts		12 months	Yes