Cells Weekly – November 3, 2013

by Alexey Bersenev on November 3, 2013 · 0 comments

in notes

Post to Twitter Send Gmail Post to LinkedIn

Cells Weekly is a digest of the most interesting news and events in stem cell research, cell therapy and regenerative medicine. Read Cells Weekly every Sunday night! Spread the word about Cells Weekly!

1. Interactive database for cell therapy industry clinical trials
William Busa created something very cool on his web-site – the first interactive database for industry-sponsored “stem cell therapy” clinical trials. I was playing with this “heatmap database” and I was impressed.
Highly recommended to everyone!

2. Targeting leukemic stem cell niche in bone marrow
Two research groups published very interesting studies about potential therapeutic targeting of leukemia by manipulation of bone marrow niche (leukemic stem cell niche). David Scadden group demonstrated that bone marrow niche modulator parathyroid hormone can attenuates one type of experimentally-induced leukemia (CML), but enhance the other type (AML):

These results demonstrate that LSC niches in CML and AML are distinct and suggest that modulation of the BMM by PTH may be a feasible strategy to reduce LSCs, a prerequisite for the cure of CML.

The second study, published in Nature Chemical Biology, utilized high throughput screening on leukemic bone marrow stroma culture and identified a potential therapeutic agent (lovastatin):

The therapeutic targeting of LSCs is challenging because LSCs are highly similar to normal hematopoietic stem and progenitor cells (HSPCs) and are protected by stromal cells in vivo. We screened 14,718 compounds in a leukemia-stroma co-culture system for inhibition of cobblestone formation, a cellular behavior associated with stem-cell function. Among those compounds that inhibited malignant cells but spared HSPCs was the cholesterol-lowering drug lovastatin.

Both studies offer an alternative to direct targeting of leukemic stem cell.

3. Stem Cell Person of the Year 2013
Srtem cell blogger – Paul Knoepfler has announced a final results of annual award. Elena Cattaneo is the winner of Stem Cell Person of the Year 2013 award. She is respected Italian stem cell scientists. But what capture attention to her figure in 2013 particularly, is Stamina controversy:

She and a dozen fellow Italian scientists stood up to what was a flawed Italian governmental decision to allow Stamina to proceed with a gutsy letter. It takes courage to not only do your research, but also to take a stand against your own government’s flawed decision and ultimately prevail. Her actions have helped to keep thousands of patients safer and protect the stem cell field.

I’m not sure how she were able to beat the first 3 guys from the poll a week before.

4. New adipose cell products launched on a market
Australian company Regeneus has launched adipose SVF (stromal vascular fraction) product HiQCell for musculoskeletal conditions (knee osteoarthritis) on local market. Interestingly, some media reports mentioned:

With the patient’s own cells are used, approval is not required from drug gatekeepers such as the local Therapeutic Goods Administration and the US Food and Drug Administration, as they are technically surgical procedures rather than drugs.
Regeneus is product driven first and foremost. It also sells two products, AdiCell and CryoShot, to treat similar musculoskeletal conditions in dogs and horses.

Cellular Biomedicine Group announces new adipose tissue-related product approved for market in China – A-Stromal kit and ProCeller processing platform for SVF:

The A-Stromal™ kit was developed completely in-house by Cellular Biomedicine Group, Inc. and is covered by two China patents. The China Food and Drug Administration (CFDA) approved this kit as a medical device and it is the first certified product of its kind in China.

ProCeller is an integrated, all-in-one computerized platform that offers a miniature cleanroom environment to isolate cells. The single piece of equipment is composed of a temperature controlled orbital shaker, integrated vacuum system, integrated centrifuge and HEPA filtered, self-sterilizing environment. It is a user-friendly interface with step-by-step procedures displayed on an LED screen.

5. Osiris clarifies regulatory status of its HCT/P products
The recent FDA letter to US-based stem cell therapeutic company Osiris, has caused a lot of questions and confusions. 2 days ago, during 3rd quarter results report, the company clarified this confusion. The explanation is very long, bu I’d like to quote the most important parts (emphasis is mine):

We received an initial communication from the FDA in the form of an untitled letter. As a result of that, we’ve had conversations and discussions very productive and collaborative. They didn’t take long to resolve. In fact, it was something like within 72 hours, we had reached an agreement in principle with the Food and Drug Administration. As part of that agreement, was that the FDA will have the opportunity to review any communication we made about the agreement prior to us making the agreement public. The way things worked out, and in quite unusual form, the government shut down the evening we reached this agreement, in principle, without FDA having the opportunity to review the press release before it went out. And so the agreement we had with the FDA was that we would not make anything public until they have the opportunity to review it. And so, on the 18th, when the Food and Drug Administration effectively started operating again, for this type of material, they were able to review the communications that we put out, commented on them and then we were able to release this.”

“Another point I wish to make is that a biologic license application is not required for Grafix to remain on the market. The reason for this, is that the FDA is positioned now and this is contrary to what they wrote in their initial letter is that Grafix as a wound cover for the treatment of acute and chronic wound is solely regulated under section 361. So there is no regulatory risk associated with not getting a BLA for Grafix.

If FDA really made a mistake in that letter, I’d love to see a proof and hear from the agency. Osiris is an example of company, which switched business strategy from 351 to 361 regulatory pathway.

6. Direct reprogramming of kidney cells
Group of researches used 6 defined factors to reprogram mature kidney cells into embryonic nephron progenitors:

…these results suggest that reinitiation of kidney development from a population of adult cells by generating embryonic progenitors may be feasible, opening the way for additional cellular and bioengineering approaches to renal repair and regeneration.

7. Comparison 2 different cell types for diabetic foot limb ischemia
Autologous bone marrow mononuclear cell and peripheral blood progenitor cell were compared versus placebo in diabetic foot limb ischemia:

Our study showed a superior benefit of bone marrow cells and peripheral blood cell treatments of critical limb ischaemia in patients with diabetic foot disease when compared with conservative therapy. There was no difference between both cell therapy groups, and no patient demonstrated signs of systemic vasculogenesis.

8. Role of macrophages in commercialized cellular product Ixmyelocel-T
US-based company Aastrom Biosciences is commercializing autologous bone marrow-derived cellular product Ixmyelocel-T for regenerative medicine. Two recent publications (1/2) uncover a role of macrophages in Ixmyelocel-T:

Ixmyelocel-T therapy contains a unique population of M2-like macrophages that are characterized by expression of M2 markers, decreased secretion of pro-inflammatory cytokines after inflammatory stimuli, and efficient removal of apoptotic cells.

Ixmyelocel-T macrophages influx modified cholesterol, remain anti-inflammatory in the face of lipid loading and inflammatory challenge, and display enhanced cholesterol efflux capabilities.

I think, Ixmyelocel-T example is interesting, because usually any bone marrow expanded product are commercializing as “stem cell products”. But if expansion process started from not purified populations, we should not underestimate a therapeutic value of mature cell types.

{ 0 comments… add one now }

Leave a Comment

Previous post:

Next post: