I do expect that we will have it in place in Q2 for the next DSMB and the scheduling of that DSMB, may be very much dated, I’m getting this in place and if we don’t get it in place, we’ll still have a DSMB meeting, I expect in Q2, but my expectation is we will get it in place. As regard to your second question on the status with BCDA-02 for the patients with chronic myocardial ischemia. So our expectation is the rolling cohort is up to 10 patients, and based on the experience we’ve had so far, the logistics of the therapy, there’s really no issues. It’s very much what we have been doing in the cardiac heart failure trial. There are some things with respect to patient inclusion exclusion, and for folks on the call, this is a therapy that was initially advanced by Baxter Healthcare.
They initiated a Phase III renew trial with a different cell therapy and different delivery approach, but it was an intramyocardial CD34 approach for chronic myocardial ischemia. And much of their data was excellent, but they stopped the trial for business reasons after they enrolled a 100 patients. The answer is we kind of know why now and so we are working through some of the issues in the trial design that we borrowed some of the significant elements from their effort because it was so successful. But we are also in terms of efficacy for the patients, which is the goal, but we are looking at potentially modifying elements of the trial to make this go much smoother downstream and help the enrolment go much faster. Also as we’re pushing all these elements on the CardiAMP heart failure trial, the third program of the neurokinin-1 selected mesenchymal, excuse me, the neurokinin-1 receptor positive mesenchymal stem cells that we’re advancing, those we think are actually an enhance enrolment in the lead program as well.
And so a lot of these things dovetail nicely together. Patients who are excluded from CardiAMP because their ejection fraction is too high can qualify for the chronic myocardial ischemia trial. Patients who have poor bone marrow for therapy based on the data, they can qualify for the allogeneic culture-expanded mesenchymal stem cell trial. So we’re trying to do this in a way that really meets all of the patient’s needs and it gives us really three shots on goal.
James Molloy: Thank you for that answer. That dovetail nicely actually. You guys guide to second quarter ’23 for getting the O3 trial kicking off, and then O4 you’re saying is behind O3. Any guidance on how far behind?
Peter Altman: At this point in time, I want to be humbler, the cell manufacturing, last year, the long term lot release testing, it wasn’t the actual manufacturing, but it was some of the datasets that we need after we’ve manufactured the cells that delayed the timeline. We had the — we decided to prioritize the cardiac because we have those patients already. So as you might expect being a 100-plus odd patients downstream in BCDA-01 that with a cell population analysis, it roughly excludes 30% of the patients. That would mean we have 30-plus patients that would like cell therapy for the ischemic heart failure and can’t have it. And that have already presented at the centers. So we have patients that we could potentially bring into that trial immediately. And so that’s something that we’re going to be starting with and we think that enhances the lead program as well.
James Molloy: Great. Thank you for taking the questions.
Peter Altman: Appreciate James, you have a great day.
Operator: And this concludes our question-and-answer session. I would now like to turn the call back over to Dr. Peter Altman for any closure remarks.
Peter Altman: Thank you, Joe. I want to thank all of you for participating on today’s call and for your interest in BioCardia. We look forward to sharing our continued progress. Thanks. Stay healthy, be kind, and have a wonderful day.
Operator: The conference has now concluded. Thank you very much for attending today’s presentation. You may now disconnect your lines.
