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| Name | Class |
|---|---|
| Unity Health Toronto | OTHER |
| Sir Mortimer B. Davis - Jewish General Hospital | OTHER |
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The primary objective is to establish the safety of autologous progenitor cell-based gene therapy of heNOS in patients with severe Pulmonary Arterial Hypertension(PAH) refractory to conventional treatment.
This is a two centre, phase I clinical trial. A total of 18 patients will be studied using an open-label, dose escaling protocol; three patients will be entered into each of the five dosing panels. An additional three patients will be entered into the final dose panel to establish safety at the maximum tolerated dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eNOS transfected EPCs | Experimental | eNOS transfected EPCs will be delivered by injection via a PA line, incremental doses over three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eNOS transfected EPCs will be delivered via a PA line | Biological | incremental dosing over 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoints will be related to the tolerability and safety of injection of genetically engineered progenitor cells in patients with severe PAH. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Potential efficacy of this approach will be assessed by changes in hemodynamic pressures, patient perceived quality of life and exercise capacity | 3 month post cell delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Granton, MD | St. Michael's Hospital and University Health Network | Principal Investigator |
| David Langleben, MD | Sir Mortimer B. Davis - Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital | Toronto | Ontario | M5B1W8 | Canada | ||
| Sir Mortimer B. Davis - Jewish General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26195220 | Derived | Granton J, Langleben D, Kutryk MB, Camack N, Galipeau J, Courtman DW, Stewart DJ. Endothelial NO-Synthase Gene-Enhanced Progenitor Cell Therapy for Pulmonary Arterial Hypertension: The PHACeT Trial. Circ Res. 2015 Sep 11;117(7):645-54. doi: 10.1161/CIRCRESAHA.114.305951. Epub 2015 Jul 20. | |
| 24267310 | Derived |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| O'Connell C, O'Callaghan DS, Humbert M. Novel medical therapies for pulmonary arterial hypertension. Clin Chest Med. 2013 Dec;34(4):867-80. doi: 10.1016/j.ccm.2013.08.002. |
| D002318 |
| Cardiovascular Diseases |