Friday, 22 March 2013

Researchers use menstrual blood stem cells to treat heart failure

Medistem, announced today via a press release that it has updated the paper regarding its Phase II clinical trial on patients with heart failure. Purpose of the trial is to assess the safety and efficacy of Medistem's proprietary type of stem cell called  "Endometrial Regenerative Cell" (ERC).

Picture of medistem's logo
Medistem's Logo
According to Medistem, ERCs are mesenchymal-like stem cells derived from menstrual blood, first discovered by the company in 2007. Alan Lewis, CEO of Medistem, explains that these stem cells are extracted from a small amount of menstrual blood taken from healthy, young donors. He adds that their  "FDA-cleared manufacturing protocol" allows the creation of up to 20,000 stem cell doses originating from just one donation.

The company claims that ERCs have the following advances:
  • Unlike stem cells taken from bone marrow, the extraction process of ERCs is non-invasive and painless
  • The cells can be administered without any fears of immune-response
  • Taking immunosuppressive drugs is not required after the transplantation
  • ERCs can be easily cryo-preserved, ready to be provided at any time as an allogeneic therapy, without any prior manipulation required

"This feature (referring to the latter) could make it practical for clinicians to efficiently deliver stem cell therapy to large numbers of heart failure patients." says Lewis.

Furthermore and according to the study's paper, during the trial the stem cells are injected into the heart via a "novel" and minimally invasive method that has been shown to be both safe and more effective than all the other methods used in similar stem cell trials for heart disease.

As aforementioned, purpose of the trial is to examine the safety and efficacy of  ERCs in the treatment of congestive heart failure. During the trial, the patients are divided into 3 groups, each group receiving a different dosage of cells, 50, 100, and 200 million cells respectively.  The study is placebo controlled and a total of 60 patients is expected to enrol. For now, only 17 patients have been treated. Patients are examined for improvements at 3 month, 6 month and 1 year post-op.

At present no serious adverse effects have been reported in any of the treated patients although the paper makes no mention of improvements, as it is probably too early.

The paper concludes that if the trial is successful it will "position Medistem to spearhead the development of a true cardiovascular regenerative therapy" !

Medistem is a San Diego-based biomedical company focused in the development of Endometrial Regenerative Cells (ERCs), a "universal donor adult stem cell product". The company says that these stem cells have the capacity to differentiate into lung, liver, heart, brain, bone, cartilage, fat and pancreatic tissue. Medistem has received clearance by the FDA to begin studies in the United States.

Video about Medistem

Bockeria, L., Bogin, V., Bockeria, O., Le, T., Alekyan, B., Woods, E., Brown, A., Ichim, T., & Patel, A. (2013). Endometrial regenerative cells for treatment of heart failure: a new stem cell enters the clinic Journal of Translational Medicine, 11 (1) DOI: 10.1186/1479-5876-11-56

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