Cells Weekly – October 28, 2012

by Alexey Bersenev on October 28, 2012 · 1 comment

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Welcome to Cells Weekly! This is an editor’s pick of the most interesting events and news in stem cell research, cell therapy and regenerative medicine. Follow us and stay tuned!

1. Replacement of defective mitochondria in human oocytes
To me, it was the most interesting scientific paper of the week. Shoukhrat Mitalipov’s team was able to swap mithochondrial DNA (spindle–chromosomal complex transfer) between human oocytes and derive “healthy embryos”. This is a new technique for potential treatment of inherited mithochondrial diseases. Mitalipov commented on clinical readiness of this methodology:

The method needs to be tweaked to increase efficiency and gain regulatory clearance, but it is ready for the clinic, says Mitalipov. “You can expect the first healthy child to be born [using this method] within three years.”

@ArthurCaplan commented on possible ethical issues:

When you change genes in an egg, even in the mitochondria of an egg, you make a change that is inherited by every single offspring of any child created from that egg. That is called germline engineering — meaning changing inherited genetic material.

And germline engineering of mitochondria crosses the line from using genetic engineering to fix our body parts into directly engineering the traits of our children. It is a road that could lead, in the distant future, toward eugenics.

2. Mesenchymal stromal cells improve dry eye syndrome in patients with GVHD
Very interesting observation was made by Chinese investigators during GVHD trial – some patients demonstrated significant improvement in dry eye syndrome. Now, they extended this observation and published results in Molecular Therapy. Allogeneic mesenchymal stromal cells were infused intravenously in 22 patients with chronic GVHD:

The symptoms of 12 out of 22 patients abated after MSCs transplantation by intravenous injection, improving in the dry eye scores, ocular surface disease index scores and the Schirmer test results.

3. State of Texas as a new “stem cell paradise”
This week, the first Stem Cell Summit was held in Houston, Texas. One of the most discussed things was the speech of Texas Governor Rick Perry. Everybody were eagerly waiting his comments on recent FDA pressure on CellTex. The comment was the following:

I disagree with the FDA that the process of what’s going on here in Texas in some of our companies is creating a drug. No more so than bone marrow transplants are not regulated by the FDA or in vitro fertilization is not regulated by them.

He also commented on California’s CIRM support of stem cell research:

California, for instance, made the decision to focus on embryonic stem cells. We don’t agree with that in Texas on moral grounds and, frankly, on scientific grounds.

He called RegenMed business developers and researchers come in Texas. With his powerful support, Texas can become a new “stem cell Mecca”.
Read my comment here.

4. Stem cell therapy IRB under scrutiny
In the last issue of Cells Weekly, we posted links to FDA warning letters for CellTex corp. and their local IRB – Texas Applied Biomedical Services. This week @LeighGTurner posted an analysis of FDA’s warning letter to Texas Applied Biomedical Services IRB. Warning letter is interesting for us, because this IRB makes decisions on cell therapy use in clinic. Because it was linked to another warning letter – to CellTex, the possibility of deeply flawed ethical review of cell therapy procedures can not be excluded:

… it is conceivable that one or more studies submitted by Celltex was reviewed and approved by a board that: does not include a physician; to date has not disclosed the identities and qualifications of independent consultants; does not maintain adequate records of meeting deliberations and votes; does not publicly disclose the identities and professional qualifications of board members; includes board members who are paid by companies to assist with preparation of study protocols and then review and approve the very protocols they prepare; and allows clinical studies to include children without having proper protocols and review practices in place.

5. How to communicate with FDA – Step-by-step guide for cell therapy developers
A guidance for cell therapy developers published in Stem Cells Translational Medicine:

This article provides an overview of the types of interactions with the FDA that are available throughout the regulatory process.

The article is freely available for registered users.

Read CIRM press-release
Read more on CIRM blog

6. Tweets from ISSCR – Roddenberry Symposium on Cellular Reprogramming
This week I was enjoying live tweets from ISSCR – Roddenberry Symposium. All stars of reprogramming in one meeting! You can see most tweets via hashtag #stemcell2012. Because twitter cut off many tweets and make it not searchable after some time, I archived tweets on storify.

7. Update on Tengion’s tissue engineered Neo-Urinary Conduit trial
We rarely hear from Tengion – the company, which try to commercialize tissue engineered organs. This week Tengion gave an update on their Neo-Urinary Conduit clinical program:

Tengion announced today the unrelated deaths of two patients enrolled in the ongoing Phase 1 clinical trial of its most advanced product candidate, the Neo-Urinary Conduit, for use in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). Tengion successfully implanted the fifth patient in the ongoing Phase 1 trial in June 2012 and the patient’s Neo-Urinary Conduit is currently functioning well with normal renal function.

It is a very tough trial. So, this update is very important.

8. New stem cell blog
The Next Regeneration – a new blog by Jalees Rehman on SciLogs platform.

In his first post – The Importance of Being Embryonic, he said:

In the wake of the announcement of the Nobel Prize, the ISSCR (whose current president is Shinya Yamanaka) wanted to pre-empt any attempts to dismiss the importance of human ESC research, which remains a cornerstone of stem cell biology and regenerative medicine. I applaud the ISSCR for this pro-active approach. Taking ethical concerns into account is important, but one also needs to make sure that scientific discoveries are not misused to put forward political or religious agendas.

Well said!
The theme and the slogan of this and next week – No political and religious agenda in stem cell research!

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That’s all for this week. Stay healthy folks!

{ 1 comment… read it below or add one }

mike October 29, 2012 at 1:04 am

thanks for the post!

stem cell meeting on the mesa this week… looking forward to your recap.. thanks

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