Human Mesenchymal Stem Cells For Acute Respiratory Distress Syndrome
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Respiratory Distress Syndrome |
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Comparison of treatment adverse event rates between the 1, 5 and 10 million cells per kilogram dose cohorts [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 9 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
This is a dose-escalation Phase 1 clinical trial with 3 cohorts with 3 subjects/cohort who will receive doses of 1 million cells/kg, 5 million cells/kg, and 10 million cells/kg. We will proceed from the lower dose to the next higher dose if there are no safety concerns for each cohort of 3 patients.
|
Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells
Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 < 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.
Exclusion Criteria:
- Age less than 18 years
- Greater than 96 hours since all inclusion criteria met
- Pregnant or breast-feeding
- Prisoner
- Presence of any active malignancy that required treatment within the last 2 years or 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
- 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
Contacts and Locations| Contact: Michael A Matthay, MD | 415-353-1206 | michael.matthay@ucsf.edu |
| Contact: Hanjing Zhuo, MPH | 415-502-7434 | hanjing.zhuo@ucsf.edu |
| United States, California | |
| University of California San Francisco Medical Center | Not yet recruiting |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: Michael A Matthay, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Taylor B Thompson, MD 617-726-2189 tthompson1@partners.org | |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01775774 History of Changes |
| Other Study ID Numbers: | MSC-ARDS-001, 1U01HL108713-01 |
| Study First Received: | January 18, 2013 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government United States: Data and Safety Monitoring Board United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
Acute Respiratory Distress Syndrome Acute Lung Injury Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |
ClinicalTrials.gov processed this record on May 16, 2013