Navigation Links
Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

The Ottawa Methods Centre, the Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group provided valuable input into the design of this clinical trial. Other co-investigators on the trial include Drs. Dean Fergusson (OHRI, uOttawa), David Courtman (OHRI, uOttawa), John Marshall (St. Michael's Hospital, University of Toronto), John Granton (University of Toronto), Brent Winston (University of Calgary), Keith Walley (St. Paul's Hospital, University of British Columbia), Shirley Mei (OHRI, uOttawa) and Manoj Lalu (OHRI, uOttawa).


Contact: Jennifer Ganton
613-798-5555 x73325
Ottawa Hospital Research Institute

Related biology news :

1. UNH researchers find African farmers need better climate change data to improve farming practices
2. Researchers attempt to solve problems of antibiotic resistance and bee deaths in one
3. UC Santa Barbara researchers discover genetic link between visual pathways of hydras and humans
4. Study by UC Santa Barbara researchers suggests that bacteria communicate by touch
5. University of Tennessee researchers invent device to rapidly detect infectious disease
6. Researchers find safer way to use common but potentially dangerous medication
7. SFU researchers help discover new HIV vaccine-related tool
8. Notre Dame researchers are providing insights into elephant behavior and conservation issues
9. Researchers develop worlds first biodegradable joint implant
10. Researchers identify novel pathway responsible for infection of a common STD pathogen
11. Researchers discover how vitamin D inhibits inflammation
Post Your Comments:
Related Image:
Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock
(Date:10/29/2015)... Oct. 29, 2015  Rubicon Genomics, Inc., today ... distribution of its DNA library preparation products, including ... new ThruPLEX Plasma-seq kit. ThruPLEX Plasma-seq has been ... of NGS libraries for liquid biopsies--the analysis of ... prognostic applications in cancer and other conditions. Eurofins ...
(Date:10/27/2015)... YORK , Oct. 27, 2015 In ... major issues of concern for various industry verticals such ... is due to the growing demand for secure & ... in various ,sectors, such as hacking of bank accounts, ... for electronic equipment such as PC,s, laptops, and smartphones ...
(Date:10/26/2015)... and LAS VEGAS , Oct. 26, ... , an innovator in modern authentication and a founding ... the launch of its latest version of the Nok ... organizations to use standards-based authentication that supports existing and ... Authentication Suite is ideal for organizations deploying customer-facing applications ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... Israel , Nov. 24, 2015  Tikcro Technologies Ltd. (OTCQB: TIKRF) ... on December 29, 2015 at 11:00 a.m. Israel ... Electra Tower, 98 Yigal Allon Street, 36 th Floor, ... of Eric Paneth and Izhak Tamir to the ... Rami Skaliter as external directors; , approval of an amendment to ...
(Date:11/24/2015)...  Twist Bioscience, a company focused on synthetic ... Bioscience chief executive officer, will present at the ... 2015 at 3:10 p.m. Eastern Time at The Lotte New ... --> --> About Twist ... on Twitter. Sign up to follow our Twitter ...
(Date:11/24/2015)... ... 24, 2015 , ... InSphero AG, the leading supplier of easy-to-use solutions for ... Aregger to serve as Chief Operating Officer. , Having joined InSphero in ... and was promoted to Head of InSphero Diagnostics in 2014. There she ...
(Date:11/24/2015)... - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" ... , President and Chief Executive Officer of ProMetic, will be ... th Annual Healthcare Conference to be held at the ... st , at 8.50am (ET) and ProMetic,s management team ... presentation will be available live via a webcast accessible at ...
Breaking Biology Technology: