Single-Injection Cell Therapy Relieves CMD Symptoms

New findings presented today at the American Heart Association (AHA) 2019 Scientific Sessions in Philadelphia showed autologous CD34+ cell therapy CLBS16 from Caladrius Biosciences significantly improved coronary flow reserve in patients with coronary microvascular dysfunction (CMD)—after just 1 intracoronary injection.

MD Mag: What was the design and intent of the ESCaPE-MD trial?

Losordo: The intent of the study was to evaluate whether these naturally occurring vascular repair cells would improve the circulation in these patients who have otherwise untreatable chest pain due to CMD (coronary microvascular dysfunction).

The patients receive 1 dose of cells, and then are followed serially for a year afterwards. The data, very interestingly, shows that for at least 6 months after a single administration, there's clear, objective evidence that new capillaries have grown, blood flow is improved, and the patients feel much, much better.

MD Mag: What are the implications for this patient population?

Losordo: So, lots of people have heard about problems in women's heart disease. It's under diagnosed, undertreated. Coronary microvascular dysfunction is probably the index example of why that's the case.

This is a disease in which the big blood vessels that can be bypassed or stented are fine. They're not blocked. But these patients have the same symptoms, and the same bad events— hospitalizations, heart failure, heart attacks—as patients who have clogged pipes. But the disease went undiagnosed for many years, because there was no test to be able to identify the function of the microcirculation.

With the development of that test, now we have a way to diagnose CMD in these patients—and they're predominantly women. Approximately 70 to 80% of patients with CMD are female. And so, in the past this was called ‘syndrome x.’

Patients would come in with chest pain that sounded like heart pain, they would have a stress test that was abnormal, and they would be brought to the catheterization laboratory for an angiogram, expecting that there was going to be something to bypass or stent. But the angiogram is done, and the vessels are wide open.

And so, before the advent of this test called coronary flow reserve, doctors didn't know what it was—they didn't even know if it was a real disease. And you can imagine as a patient, that's very, very frustrating. Now that we have this method to clearly diagnose this, we're finding that there's actually a very large population of patients out there with coronary microvascular dysfunction.

You know, people often talk about the ‘tip of the iceberg.’ This might be the iceberg.

The ESCaPE-CMD findings, which indicate symptom relief for a condition which particularly burdens women, come from a collaborative six-month follow-up research venture conducted by investigators from Cedars-Sinai, Mayo Clinic, and The Christ Hospital.

In an interview with MD Magazine® while at AHA 2019, Douglas Losordo, MD, chief medical officer of Caladrius, explained the mechanism of action observed in patients administered the CD34+ cell therapy, and what the findings mean for the particular CMD patient population.

MD Mag: What was the design and intent of the ESCaPE-MD trial?

Losordo: The intent of the study was to evaluate whether these naturally occurring vascular repair cells would improve the circulation in these patients who have otherwise untreatable chest pain due to CMD (coronary microvascular dysfunction).

The patients receive 1 dose of cells, and then are followed serially for a year afterwards. The data, very interestingly, shows that for at least 6 months after a single administration, there's clear, objective evidence that new capillaries have grown, blood flow is improved, and the patients feel much, much better.

MD Mag: What are the implications for this patient population?

Losordo: So, lots of people have heard about problems in women's heart disease. It's under diagnosed, undertreated. Coronary microvascular dysfunction is probably the index example of why that's the case.

This is a disease in which the big blood vessels that can be bypassed or stented are fine. They're not blocked. But these patients have the same symptoms, and the same bad events— hospitalizations, heart failure, heart attacks—as patients who have clogged pipes. But the disease went undiagnosed for many years, because there was no test to be able to identify the function of the microcirculation.

With the development of that test, now we have a way to diagnose CMD in these patients—and they're predominantly women. Approximately 70 to 80% of patients with CMD are female. And so, in the past this was called ‘syndrome x.’

Patients would come in with chest pain that sounded like heart pain, they would have a stress test that was abnormal, and they would be brought to the catheterization laboratory for an angiogram, expecting that there was going to be something to bypass or stent. But the angiogram is done, and the vessels are wide open.

And so, before the advent of this test called coronary flow reserve, doctors didn't know what it was—they didn't even know if it was a real disease. And you can imagine as a patient, that's very, very frustrating. Now that we have this method to clearly diagnose this, we're finding that there's actually a very large population of patients out there with coronary microvascular dysfunction.

You know, people often talk about the ‘tip of the iceberg.’ This might be the iceberg.