CELLULAR IMMUNOTHERAPY FOR SEPTIC SHOCK: CISS Phase I Trial
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1 CELLULAR IMMUNOTHERAPY FOR SEPTIC SHOCK: CISS Phase I Trial Lauralyn McIntyre, MD, FRCPC, MHSc Associate Professor, University of Ottawa Senior Scientist, Ottawa Hospital Research Institute CCCF MEETING, TORONTO, ON OCT 4, 2017
2 Disclosures Funding for CISS related work Stem Cell Network CIHR Ontario Institute for Regenerative Medicine Ontario Research Fund
3 Why study use of mesenchymal stromal cells for septic shock? 20% of all ICU admissions Mortality rate of 20-40% Long-term morbidity associated with physical, cognitive, and emotional dysfunction for survivors Estimated costs in USA: $24 billion/year Angus, D et al, NEJM, 2013: 369: ; Martin, C et al, NEJ.M 2003: 348(16): ; Levy, MM CCM, 2010: 38(2); ; Lagu, T et al, CCM. 2012: 40(3); ; Kaukonen, KM, JAMA, (13): ; Fleischmann, C et al, AJRCCM, 2016: 193(3):
4 Rationale for MSCs in Septic Shock Laroye et al, Stem Cells, 2017
5 Mei et al. AJRCCM,2010; 182(8): OR < 1 favors MSCs as compared to controls Lalu et al, elife, Nov, 2016
6 We performed an open label single-centre Phase I dose-escalation trial of freshly cultured adult allogenic bone marrow-derived MSCs in patients with septic shock to examine the safety and tolerability of MSCs in this clinical setting CISS framed as a rescue intervention
7 CISS Phase I Study Design CISS Observational Arm n = 21 CISS Interventional Arm n = 9 CISS eligibility met within 24 hours of ICU admission (additional 6 hours to enrolment) CISS eligibility met within 24 hours of ICU admission (additional 6 hours to enrolment) Consent Obtained 1 hour of pulmonary and hemodynamic stability Serial blood for inflammation At baseline, 1, 4, 12, 24, and 72 hours Record adverse events Low Dose (n = 3) 0.3 x 10 6 cells/kg Mid Dose (n = 3) 1.0 x 10 6 cells/kg High Dose (n = 3) 3.0 x 10 6 cells/kg * DSMC review after completion of each dose panel or as required L McIntyre et al, published online AJRCCM, Sept 29, 2017 Maximum Tolerated Dose Established for Phase II Trial
8 Eligibility Criteria Main inclusion criteria: Receipt of antibiotics and source control Adequate resuscitation endpoints (CVP 8 mmhg; ScV0 2 70%) Cardiovascular failure and At least 1 persistent or worsening organ failure or organ hypoperfusion Main exclusion criteria: Another dominant form of shock Severe chronic morbidities Immunesuppression History of malignancy in previous 2 years Non commitment to aggressive care (family/treating physician) L McIntyre et al, published online AJRCCM, Sept 29, 2017
9 Safety Outcomes MSC infusion events Life threatening hemodynamic or pulmonary instability up to 30 minutes post MSC infusion Expected serious adverse events Nosocomial infection - Pulmonary embolism Arrhythmias - Death 28/90 days Acute coronary syndrome - Re-admission to ICU Bleeding Serious unexpected adverse events Malignancy
10 Safety: Trial Suspension Criteria* Life threatening hemodynamic or pulmonary instability up to 30 minutes post MSC infusion OR Death within 24 hours after cessation of MSC infusion OR Serious unexpected adverse event * Event considered possibly/related to the study drug/protocol
11 CISS Baseline Characteristics Age* Sex, (female), No (%) APACHE II Score* MODS score Qualifying Organ Failure No (%) Respiratory Failure Hematologic Failure Renal Failure Organ Hypoperfusion Baseline Organ Support No (%) Vasoactive agents Ventilation Renal replacement therapy Observational Cohort (n = 21) 61 (23-95) 12 (57) 26 (17-32) 5 (1 15) 15 (71) 4 (19) 8 (38) 15 (71) 21 (100) 21 (100) 4 (19) Interventional Cohort (n = 9) 71 (38-91) 5 (56) 25 (11-28) 5 (3 10) 5 (56) 3 (33) 5 (56) 4 (44) 9 (100) 9 (100) 1 (11) * Median (Range) L McIntyre et al, published online AJRCCM, Sept 29, 2017
12 CISS Baseline Characteristics Infectious Source No (%) Lung Intra-abdominal Urinary Tract Other Observational Cohort (n = 21) 8 (38) 6 (29) 2 (10) 4 (19) Interventional Cohort (n = 9) 3 (33) 3 (33) 1 (11) 2 (22) Time to Enrolment* 19 (5 28) 24 (11 28) Dose of MSCs Received (range) Low dose (0.3 x 10 6 cells/kg) Mid dose (1.0 x 10 6 cells/kg) High dose (3.0 x 10 6 cells/kg) * Median (Range) L McIntyre et al, published online AJRCCM, Sept 29, 2017
13 Safety Outcomes No MSC infusion related serious adverse events or deaths in first 24 hours post MSC infusion No serious unexpected adverse events No safety signals for physiological measures first 72 hours Mean arterial pressure Heart rate P/F ratios Oxygenation index MODS scores first 7 days
14 Expected Serious Adverse Events Observational Cohort (n = 21) Interventional Cohort (n = 9) *No (%: 95%CI) Nosocomial bacterial infection 10 (48: 24-71) 2 (22: 0-56) Nosocomial fungal infection 5 (24: 4-44) 3 (33: 0-72) Clinically important bleeding 3 (14: 0-31) 2 (22: 0-56) Acute coronary syndrome 2 (10: 0-23) 0 (0) Tachy/bradyarrythmias 3 (14: 0-31) 4 (44: 4-85) Pulmonary embolism (PE) 2 (10: 0-23) **0(0) * Events monitored for first 28 days ** 1 event occurred 32 days post MSC infusion L McIntyre et al, published online AJRCCM, Sept 29, 2017
15 Clinical Outcomes Observational Cohort (n = 21) Interventional Cohort (n = 9) Temperature (post-pre) Infusion* 0 (-1 to 0.8) 0 (-0.9 to 0.7) Mortality No (%: 95%CI) ICU 90 days 4 (19: 1-37) 4 (19: 1-37) 2 (22: 0-56) 2 (22: 0-56) ICU length of stay (survivors)* Hospital length of stay (survivors) * ICU re-admission No (%) 13 (4-50) 12 (7-30) 21 (4-100) 29 (10-58) 3 (14) 0 (0) * Median (Range) L McIntyre et al, published online AJRCCM, Sept 29, 2017
16 Conclusion Infusion of MSCs into participants with septic shock to a dose of 3 million cells/kg appears safe Recruitment into trial is feasible 0.6 to 1.0 patients per month Logistical challenges having freshly cultured product Funding secured to initiate a Canadian multi-centre phase II RCT
17 Translational/Manufacturing Clinical Team CISS Team Background/Methods
18 Acknowledgements CISS Executive Committee Duncan Stewart - Brent Winston Dean Fergusson - Claudia dos Santos Shirley Mei - John Granton David Courtman - Shane English John Marshall - Alies Maybee Keith Walley Canadian Critical Care Trials Group Canadian Critical Care Translational Biology Group Michael Matthay
19 CISS MSCs Bone marrow derived, allogeneic, freshly cultured MSCs 1 bone marrow donor Characterized for identity (tri-lineage differentiation, cell surface marker expression), sterility, genetic stability, potency Pre-specified release criteria Viability of final cell product ranged from 89.4% to 96.3% L McIntyre et al, published online AJRCCM, Sept 29, 2017
20 Time Course Plasma Cytokine Levels ANGPT 2 RAGE IL-10 IL-1β IL-6 TNF-α (pg/ml) (pg/ml) (pg/ml) (pg/ml) (pg/ml) (pg/ml) Hours after Enrollment
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