Phase 1
N=9
Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome
Acute Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01775774 ↗Enrolled (actual)
9
Serious AEs
33.3%
Results posted
Aug 2017
Primary outcome: Primary: Incidence of Pre-specified Infusion Associated Adverse Events — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Michael A. Matthay
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Pre-specified Infusion Associated Adverse Events |
0; 0; 0 | — |
| SECONDARY Incidence of Severe Adverse Events (SAEs) |
2; 1; 0 | — |
| SECONDARY Ventilator Free Days at Study Day 28 |
18; 22; 20 | — |
| SECONDARY Duration of Vasopressor Use (Days) |
4; 2; 0 | — |
| SECONDARY ICU Free Days to Day 28 |
14; 21; 18 | — |
| SECONDARY Hospital Survival to Day 60 |
2; 2; 3 | — |
| SECONDARY Mortality at Hospital Discharge |
1; 1; 0 | — |
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.
Eligibility Criteria
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:
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio 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
- 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)
Data sourced from ClinicalTrials.gov (NCT01775774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.