Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).

Key facts

Study ID

NCT02097641

Run by

Michael A. Matthay

People needed

60

Starts

2014-03-15

Expected to finish

2018-02-09

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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)
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
• No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

You may not qualify if…

• Age less than 18 years
• Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
• Pregnant or breast-feeding
• Prisoner
• Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
• Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
• Moderate to severe liver failure (Childs-Pugh Score > 12)
• Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
• 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)
• Major trauma in the prior 5 days
• Lung transplant patient
• No consent/inability to obtain consent
• Moribund patient not expected to survive 24 hours
• World Health Organization (WHO) Class III or IV pulmonary hypertension
• Documented deep venous thrombosis or pulmonary embolism within past 3 months
• No arterial line/no intent to place an arterial line
• No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
• Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical Center — Saint Paul, Minnesota, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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