Name:
Performing a gene and cell therapy trial for heart attack patients with Duncan Stewart
Description:
Performing a gene and cell therapy trial for heart attack patients with Duncan Stewart
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T00H04M04S
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Upload Date:
2019-12-02T00:00:00.0000000
Transcript:
Language: EN.
Segment:1 Performing a gene and cell therapy trial for heart attack patients with Duncan Stewart.
[MUSIC PLAYING]
Segment:2 Please introduce yourself and the ENACT-AMI trial.
DUNCAN STEWART: My name is Duncan Stewart. So I'm the President of the Ontario Institute for Regenerative Medicine, and I'm a Researcher in the Regenerative Medicine program at the Ottawa Hospital.
Segment:3 What are the challenges of running this trial?.
DUNCAN STEWART: So we're doing a multi-center phase II clinical trial looking at the efficacy of gene enhanced endothelial progenitor cells for patients with large heart attacks. I mean, it shouldn't be underestimated.
DUNCAN STEWART: It's a complicated thing to do. So this is a fairly large trial-- 100 patients. It's multi-center, so four centers in eastern Canada. And it involves obviously all of the challenges of running a fairly large trial and doing it well, but also the manufacturing issues. We have to harvest cells from patients. It's a tautologous therapy. We have to ship the cells from the sites to the manufacturing center. We have to do the manufacturing. We have to ship the products back. So a lot of logistics need to happen perfectly.
Segment:4 What do you hope the trial will show?.
DUNCAN STEWART: But what we believe will happen is that this cell therapy will reduce the amount of scar that occurs-- will improve healing, so that rather than ending up with a heart that isn't working well-- that gets worse and worse, and the patient develops heart failure, and all of the bad things that happen after that-- we're hoping that patients that receive this therapy will heal better and will remain well, and will not develop heart failure.
DUNCAN STEWART: You know, I think there's a lot of interest, obviously, in cells. And various stem cells and progenitor cells have very interesting activity. However, I think what we're learning in the clinical trials is there's variability, and not every patient benefits. Not every cell type is as active, and even different manufacturing runs you can have different activity. So a certain amount of variability. What we've found is that the activity of the cells can be greatly enhanced by increasing the expression of key pathways that are important in their activity. So in our case, it's endothelial nitric oxide synthase, but this increases the regenerative potential of our endothelial progenitor cells. So that gives us greater efficacy and greater consistency in terms of the response.
DUNCAN STEWART: This is an autologous cell therapy. We don't have an industry partner, so we're doing this as an academic investigator-led trial. So I mean, if we have important beneficial effects I think we're going to have to look for ways that we can make this available. And I think fortunately a number of institutions across Canada and many other parts of the world are developing the clinical grade cell manufacturing facilities that are needed so we can use those to provide this kind of therapy to patients that would require it in the future.
Segment:5 Has regenerative medicine lived up to its hype?.
DUNCAN STEWART: So I think much like bone marrow transplantation, we would be able to offer this to our patients that need this if the results of this trial show that that's warranted. So I think you to have reasonable expectations. So I think it's true that a decade ago when this was quite new, people thought it'd be very simple. You just sprinkle in some cells and miracles would happen. You know, I think that's not realistic. I think the potential is certainly there. I think there's no question that these approaches will be transformative, but I think it takes time to be able to get the technologies where they need to be and be able to do it in the way that you need to get the full benefit. A good example would be the CAR T therapy. I mean, that was a 20-year journey before everything aligned so you could get the kind of benefit we've seen in some patients with leukemia. And I think it's the same for regenerative medicine. So I think we're getting there. I think this trial is an important step on that journey as we're combining cells and genes, and our preclinical data I think would suggest that this is very effective. So I'm hopeful that this will be a breakthrough trial.
