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| Name | Class |
|---|---|
| Athersys Limited | INDUSTRY |
| Cell Therapy Catapult | OTHER |
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A study to examine the safety (and potential efficacy) of the adult stem cell investigational product, MultiStem, in adults who have Acute Respiratory Distress Syndrome (ARDS). The primary hypothesis is that MultiStem will be safe in ARDS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Low dose MultiStem |
|
| Cohort 2 | Experimental | High dose MultiStem |
|
| Cohort 3 | Experimental | Highest safe MultiStem dose (from Cohorts 1 and 2) or Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiStem | Biological |
| ||
| MultiStem |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of sustained hypoxemia or hypotension | 4 hours | |
| Suspected Unexpected Serious Adverse Reactions (SUSARs) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Up to 365 days | |
| Changes in vital signs | Up to 7 days | |
| Changes in blood safety laboratories |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in exploratory blood inflammatory markers | Up to 7 days | |
| Changes in exploratory blood immune markers | Up to 7 days | |
| Quality of Life (QoL) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoff Bellingan, MD | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals - Cleveland Medical Center | Cleveland | Ohio | 44106 | United States | ||
| Hospital of the University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34811567 | Derived | Bellingan G, Jacono F, Bannard-Smith J, Brealey D, Meyer N, Thickett D, Young D, Bentley A, McVerry BJ, Wunderink RG, Doerschug KC, Summers C, Rojas M, Ting A, Jenkins ED. Safety and efficacy of multipotent adult progenitor cells in acute respiratory distress syndrome (MUST-ARDS): a multicentre, randomised, double-blind, placebo-controlled phase 1/2 trial. Intensive Care Med. 2022 Jan;48(1):36-44. doi: 10.1007/s00134-021-06570-4. Epub 2021 Nov 23. |
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|
| Placebo | Biological |
|
| Up to 7 days |
| Ventilator-free days | 28 days |
| ICU-free days | 28 days |
| Total length of hospital stay | 28 days |
| All-cause mortality | 28 days |
| Changes in levels of oxygenation | Up to 28 days |
| Changes in positive end-expiratory airway pressure | Up to 28 days |
| Changes in respiratory physiologic measures including lung compliance and airway resistance (peak and plateau pressures) | Up to Day 365 |
| All-cause mortality | Up to Day 365 |
| Up to 365 days |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University College London Hospital | London | NW12BU | United Kingdom |
| St. Georges Hospital | London | SW17 0QT | United Kingdom |
| Manchester Royal Infirmary | Manchester | M139WL | United Kingdom |
| Wythenshawe Hospital | Manchester | M239LT | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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