Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome



Status:Recruiting
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:July 2013
End Date:February 2017
Contact:Michael A Matthay, MD
Email:michael.matthay@ucsf.edu
Phone:415-353-1206

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

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.

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.

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)
We found this trial at
4
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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