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Longeveron Begins Enrollment of Second Cohort of Phase 1 Alzheimer’s Disease Trial

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MIAMI, May 10, 2017 — Longeveron companyLongeveron, a regenerative medicine company, announced that their Phase 1 Alzheimer’s disease trial will proceed with enrollment at the recommendation of an independent Data Monitoring Committee (DMC) which reviewed data from the trial’s safety run-in phase.

The clinical trial is designed to assess the safety, tolerability and efficacy of intravenous infusion of two different doses of Longeveron mesenchymal stem cells (LMSCs) compared to placebo. The DMC reviewed safety data from a five-patient run-in phase where subjects diagnosed with Alzheimer’s disease were given a single infusion of either LMSCs or placebo. Longeveron now has the green light to continue the trial.

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Cynata’s “Major Breakthrough” in MSC Manufacturing – Unlimited Quantities, Uniform Batches, Single Donor, & Low Cost

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For years, it has been clear that mesenchymal stem cells (MSCs) are a leading type of stem cell being investigated for therapeutic applications, as they have the potential to treat a wide range of acute and degenerative diseases. In addition to secreting factors that can stimulate tissue repair, MSCs can substantially alter their microenvironment, exerting effects that are both anti-inflammatory and anti-fibrotic.

MSCs are also advantageous over other stem cells types, because they avoid the ethical issues that surround embryonic stem cell research and appear to be immuno-privileged. Importantly, MSCs also well-suited for use in the exponential growth area of 3D printing, because of their unusual capacity to form structural tissues. [Read more…]

Current Landscape for Stem Cell Clinical Trials

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To understand the growing market potential for stem cell therapies, it is critical to consider the current landscape for stem cell clinical trials.

ClinicalTrials.govThere are 5561 clinical trials found when the term “stem cells” is searched on ClinicalTrials.gov, indicating that there are now thousands of stem cell trials underway worldwide. (Search executed November 7, 2016.)

ClinicalTrials.gov is the global registry of publicly and privately supported clinical studies involving human patients. While not a comprehensive resource, it contains approximately three-quarters of registered cell therapy trials worldwide.

Below is a map showing the location of current stem cell clinical trials.

Map of Stem Cell Clinical Trials, by Geographical Region

Map of Stem Cell Clinical Trials

“Hotspots” for Stem Cell Clinical Trial Activity

Clearly, North America (3057 trials) and Europe (1288 trials) are “hotspots” for stem cell clinical trial activity.

Among the North American trials, nearly all of them of them are occurring in the United States (2935).  [Read more…]

Analyzing the Mesenchymal Stem Cell (MSC) Market Using Social Analytics

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Twitter Metrics for BioInformant - @StemCellMartketOne of the ways to use market intelligence to analyze trends within the mesenchymal stem cell (MSC) market is to assess how the cell type is being discussed on leading social media platforms, such as Twitter.

Twitter.com is one of the most widely used social media platforms today. It has with 316 million monthly active users and 500 million Tweets sent per day, according to Twitter’s company statistics. 

It is also the 9th most visited website in the world, an impressive accomplishment.

Social Analytics Reveal Key Trends about Mesenchymal Stem Cell (MSC) Research

The figure below shows a hashtag map for the term “#mesenchymal.” It was produced using the  social analytics platform Hashtagify.me.

The linked topics shown as spokes in this figure represent the top hashtags that are used together with the hashtag “#mesenchymal” on Twitter.
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Mesoblast Securing IP Portfolio for Use of Mesenchymal Precursor Cells

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Mesoblast has been granted a key patent by the United States Patent and Trademark Office (USPTO) for use of its Mesenchymal Precursor Cells (MPCs) in the treatment of rheumatic diseases, including rheumatoid arthritis (RA). Mesoblast is global company that specializes in developing cell-based therapies that utilize mesenchymal precursor cells (MPCs) and mesenchymal stem cells (MSCs).

The Company’s patent portfolio in the United States for the treatment of RA and related conditions “comprises the newly and recently granted patents, US 9,381,216 and US 9,265,796, which cover treatment of rheumatic diseases by administration of STRO-1 positive MPCs.”

According to Dr. Allan Gibofsky, Professor at Weill Cornell Medical College, “The trial used standardized parameters consistent with United States Food and Drug Administration (FDA) guidance for RA product development. Importantly, there was consistency observed in the dose-related responses for clinical symptoms, physical function and disease activity parameters at 12 weeks in line with the trial’s pre-specified efficacy endpoints.”

To learn more, view the Mesoblast press announcement.

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