Hurray for Neostem!
The results of its clinical trial were released yesterday, and they are positive (from a CR Way perspective). Here is Robin Smith, the CEO of Neostem, explaining the results.
Here is the press release:
5:16 pm Neostem announces initial ‘positive’ data from Phase 2 PreSERVE AMI clinical trial : Co announced initial positive data from its 161 patient Phase 2 PreSERVE AMI (or acute myocardial infarction) clinical trial. These data are based on all enrolled patients being treated and having received six month follow-up for imaging and twelve month median length follow up for:
- Mortality
- Adverse events
- Serious adverse events (SAEs)
- Major adverse cardiac events (MACE).
Highlights of the initial results include:
- A statistically significant mortality benefit (p
- A statistically significant dose-dependent reduction in SAEs (p
- Observation of a dose-dependent numerical decrease in MACE. MACE occurred in 14% of control subjects, in 17% of subjects of who received less than 14 million CD34 cells, in 10% of subjects who received greater than 14 million CD34 cells, and in 7% of subjects who received greater than 20 million CD34 cells.
- When correcting for the time to stent implantation in all subjects, patients treated with CD34 cells were seen to have a statistically significant dose-dependent improvement in their ejection fraction (p
- No meaningful difference in perfusion, as evidenced by SPECT imaging, between the treatment and the control group from baseline to 6 months in resting total severity score (:RTSS) suggesting this may not be a future suitable tool to assess NBS10, which is consistent with U.S. Food and Drug Administration (:FDA) guidance that mortality and MACE are the appropriate approvable endpoints to determine efficacy of a cellular therapy for cardiac disease as opposed to imaging endpoints.
The report mentions that the stem cells did not improve perfusion. That’s a big deal for some Wall Street investors since perfusion is the endpoint for the phase 2 trial that was reported. However, I think it is a mistake to target perfusion as an endpoint. As I understand it, perfusion measures the amount of blood delivered to a particular tissue. A cardiac perfusion scan measures the amount of blood in your heart muscle at rest and while exercising. Many of you are very familiar with a stress myocardial perfusion scan, which is used to assess the blood flow to the heart muscle (myocardium) when it is stressed . (Read more).
The PreSERVE AMI clinical trial proved that an injection of stem cells to the heart could hasten repair of actual tissue damage. Making much difference in perfusion, I would think, would be contingent upon the patient’s utilization of the stem cell influx through exercise, diet, and other lifestyle factors. Patients themselves must take responsibility for this aspect of improvement. Did some trial participants expect a magical bullet that erases the effects of lack of exercise and an unhealthy diet?
Most LivingTheCRWay members who read this have an elaborate cardiovascular regimen that has made improvement in their cardiovascular health. So if they got an infusion of stem cells like the patients in this trial, most likely their heart would benefit. On the other hand, if you relied on a stem cell influx without following a CR Way lifestyle, the chances of failure or mediocre results are greater.
We have been refining CR Way living for years, preparing for stem cell input safely and effectively. The Neostem trial helps us understand that we are on the right track and that stem cell infusion has excellent chances of working in a metabolic environment that is stem cell friendly.
Paul
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