Cryo-Cell Provides Funding for Cord Blood Clinical Trial Application to Treat ALS

Oldsmar, FL (PRWEB) August 22, 2014

This funding was made through an additional investment in Cryo-Cells cell therapy research affiliate, Saneron CCEL Therapeutics, Inc. in the form of a convertible promissory note purchase agreement.

Cryo-Cell is extremely pleased to collaborate with Saneron on several fronts to enable the filing of an IND, which we hope will lead to regenerative therapies using cord blood to treat devastating neurodegenerative diseases such as ALS, David Portnoy, Chairman and Co-CEO of Cryo-Cell, stated. He continued, Although this is only the next step, if Sanerons cord blood product ultimately is successfully approved by the FDA to treat ALS, Saneron will indeed prove to be a very valuable corporate asset for Cryo-Cell.

With these funds, Saneron anticipates filing an IND application in the fourth quarter of 2014. The IND for the FDA will be for a Phase I Safety trial enrolling 12 patients that have been diagnosed with ALS, said Nicole Kuzmin-Nichols, President & COO of Saneron. The study will involve the administration of U-CORD-CELL, Sanerons proprietary mononuclear enriched cell fraction of umbilical cord blood to be processed in Cryo-Cells GMP laboratory.

Sanerons sponsored preclinical studies using U-CORD-CELL have demonstrated efficacy in various disease models including: ALS, stroke, myocardial infarction, and Alzheimers disease. In particular, the Cryo-Cell affiliate has demonstrated that a single intravenous administration of U-CORD-CELL can delay disease progression and extend lifespan in a preclinical ALS animal model.

Cryo-Cell is excited that Sanerons U-CORD-CELL processed cell fraction has shown improved efficacy in the ALS preclinical model when previously compared to commonly utilized cord blood cell processing procedures used in the cord blood banking industry.

ALS is a devastating disease that is a rapidly progressive, invariably fatal neurological disease that attacks the nerve cells (neurons) responsible for controlling voluntary muscles (muscle action we are able to control, such as those in the arms, legs, and face). The disease belongs to a group of disorders known as motor neuron diseases, which are characterized by the gradual degeneration and death of motor neurons. According to the ALS Association, in the U.S., approximately 30,000 people have ALS and each year 5,000 people are diagnosed with the disease.

About Cryo-Cell International

Founded in 1989, (OTCQB:CCEL) Cryo-Cell International, Inc. is the world's first private cord blood bank. More than 500,000 parents from 87 countries trust Cryo-Cell to preserve their family members' stem cells. Cryo-Cell's mission is to provide clients with state-of-the-art stem cell cryopreservation services and support the advancement of regenerative medicine. Cryo-Cell operates in a facility that is FDA registered, cGMP-/cGTP-compliant and is licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell is also the first U.S. (for private use only) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. In addition, Cryo-Cell is ISO 9001:2008 certified by BSI, an internationally recognized, quality assessment organization. Cryo-Cell is a publicly traded company, OTCQB: CCEL. For more information, please visit http://www.cryo-cell.com.

About Saneron CCEL Therapeutics, Inc.

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Cryo-Cell Provides Funding for Cord Blood Clinical Trial Application to Treat ALS

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31 2 Mrs. Han -C4-C6 Spinal Cord Injury (Female, 39-year-old) - After stem cell treatment - Video

Suzanne Somers Uses Novel Stem Cell Therapy During Breast …

Breast cancer strikes more than 200,000 American women each year.1

About 40,000 die from metastatic disease, leaving 160,000 women alivebut with missing or disfigured breasts.2

For most women, the principal options to reverse the mutilating impact of conventional therapy (lumpectomy or mastectomy plus radiation) are reconstructive surgery using synthetic breast implants or, for women who don't want artificial implants, surgical stripping of abdominal or back muscles which are then used to reconstruct the breast.

Both of these reconstructive procedures can involve side effects such as chronic pain and discomfort not only in the breast area, but from hernias and weakness from the donor site of the body, including muscles in the back or abdomen that are surgically removed.3-6

Seldom do any of these conventional reconstruction choices restore the desired sensation, mobility, comfort, and appearance of the original healthy breast.

There is, however, another option used by some plastic surgeons in the past called autologous fat grafting, or fat transplantation. This procedure utilizes the patient's own subcutaneous fat tissue from other regions of the body and implants it into the breast. A major concern with this kind of breast restoration is that scientific studies have failed to show clear evidence of long-term viability of the fat transplanted into the breast.7 That's why the concept of enriching transplanted fat with concentrated stem cells offers such incredible potential.

Actress Suzanne Somers was diagnosed with breast cancer in 2001. She had a lumpectomy to remove the tumor, followed by intense radiation therapy.

For those who don't know, the destructive effects of surgery combined with high-dose radiation can cause severe disfigurement to breast tissues. Even breast conserving/reconstruction surgeries don't always restore and maintain post-treatment breasts anywhere near their original appearance.

Those who know Suzanne Somers understand that she does not make important medical decisions in a conventional way. Rather than submitting to traditional breast reconstructive surgery, she scoured the world to identify researchers who were using advanced techniques to improve autologous fat transplantation as a long-term restorative procedure for the breast.

Though preliminary, the results thus far have been impressive. Using an advanced technique conceived by Dr. Kotaro Yoshimura in Japan, Suzanne's American surgeon utilized a novel strategy known as Cell-Assisted Lipotransfer.8 Dr. Yoshimura's protocol utilizes autologous adipose-derived stem cells in combination with liposuction techniques.

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Suzanne Somers Uses Novel Stem Cell Therapy During Breast ...

AFL approves stem-cell therapy treatment

An Australian-based biomedical company has been given approval from the AFL to use stem-cell therapy on players recovering from injury.

Sydney-based Regeneus has revealed it was recently given permission for its HiQCell treatment on players suffering from such issues as osteoarthritis and tendinopathy.

The treatment is banned by the World Anti-Doping Agency if it is performance-enhancing but allowed if it is solely to treat injuries.

Regeneus commercial development director Steven Barberasaid the regenerative medicine company had sought approval from the AFL for what the company says is "innovative but not experimental" treatment.

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"In 2013, Regeneus sought and received clearance from ASADA [Australian Sports Anti-Doping Authority] for its proprietary HiQCell therapy for use with athletes who participate in sporting competitions subject to the WADA Anti-Doping Code. The AFL is one of many professional sports bodies which applies the WADA Anti-Doping Code within its regulations for players," he said.

"In March this year, the AFL introduced a Prohibited Treatments List as an additional level of scrutiny over and above the WADA code for player treatments. In light of this, Regeneus made a submission to the AFL to confirm that our specific treatment is not prohibited under that list. Subsequently, the chief medical officer of the AFL has recently communicated with our primary Melbourne-based HiQCell medical practitioner that the treatment is not prohibited and can be administered on a case-by-case basis to players.

"We anticipate documented confirmation of this outcome in the near future from the AFL.

"To our knowledge, the permission is specific to HiQCell and not necessarily to cell-based therapies in general."

The AFL confirmed it had given approval on a "case-by-case" basis.

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AFL approves stem-cell therapy treatment

ReNeuron jumps on stem cell study results

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Shares in AIM-listed stem cell business ReNeuron Group rose on Tuesday morning after the group unveiled details of progress with the PISCES clinical trial of its ReN001 stem cell therapy for disabled stroke patients.

The group said that the primary aim of the study was to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells in patients with moderate to severe functional neurological impairments resulting from their stroke.

The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.

Interim data from the first nine patients treated in the PISCES study was being presented by the clinical team from Glasgow's Southern General Hospital at the 22nd European Stroke Conference, taking place in London this week, the group said.

It added that there was no cell-related or immunological adverse events reported in any of the patients treated and sustained reductions in neurological impairment and spasticity were observed in most patients compared with their stable pre-treatment baseline performance.

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ReNeuron jumps on stem cell study results

ViaCyte gets $20M for diabetes therapy trials

Human embryonic stem cells were differentiated into cells of the pancreas (blue). These cells give rise to insulin-producing cells (red). When implanted into mice, the stem cell-derived pancreatic cells effectively replace the insulin lost in type 1 diabetes. San Diego-based ViaCyte is developing an implantable artificial pancreas derived from human embryonic stem cells. Its work is funded in part by grants from the California Institute for Regenerative Medicine.

San Diego's ViaCyte has received $20 million from a drug company to advance its stem cell-based therapy for type 1 diabetes into clinical trials.

ViaCyte's agreement with Janssen Pharmaceuticals, a Johnson & Johnson company, comes days after the company announced receiving the go-ahead from the U.S. Food and Drug Administration to begin clinical trials. The agreement also includes the company's investment fund, Johnson & Johnson Development Corporation.

ViaCyte's experimental product, VC-01, is derived from human embryonic stem cells. These cells are matured into cells that regulate blood sugar levels. These includes cells that make insulin, which lowers blood sugar, in addition to cells that make glucagon, which raises blood sugar levels. It's believed that recreating this natural complement of hormones will be more effective than administering insulin alone.

The cells are encapsulated into a semi-permeable pouch that allows the hormones to enter the bloodstream, and nutrients from the bloodstream to enter cells, but keeps out the immune system, which would otherwise attack the cells.

The California Institute for Regenerative Medicine (CIRM), the states stem cell agency, has awarded ViaCyte more than $38 million to help develop the treatment over the past six years.

The money will mostly be used to advance clinical development of the product, ViaCyte said. The agreement also gives Janssen the right to "consider a longer-term transaction" related to the product.

This is excellent news as it demonstrates that pharmaceutical companies are recognizing stem cell therapies hold tremendous promise and need to be part of their development portfolio, CIRM president and CEO C. Randal Mills said in a statement. This kind of serious financial commitment from industry is vital in helping get promising therapies like this through all the phases of clinical trials and, most importantly, to the patients in need.

ViaCyte had also recently received $5.4 million in private equity financing.

These important transactions provide us with the additional resources we need to pursue the further development of the VC-01 product candidate as a potential new treatment option for patients with type 1 diabetes, said Paul Laikind, Ph.D., ViaCyte's president and CEO, in the statement. We are pleased to be extending our relationship with Janssen and JJDC is this area of mutual interest.

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ViaCyte gets $20M for diabetes therapy trials

Ohio diocese discourages ALS Association ice bucket challenge, cites embryonic stem cell funds

The Canadian Press - ONLINE EDITION

By: Amanda Lee Myers, The Associated Press

Thursday, Aug. 21, 2014 at 3:23 PM | Comments: 0

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Major League Baseball Commissioner-elect Rob Manfred participates in the ALS Ice-Bucket Challenge outside the organization's headquarters in New York, Wednesday, Aug. 20, 2014. Manfred participated with more than 160 other MLB employees to raise more than $16,000 for the ALS Association. (AP Photo/Vanessa A. Alvarez)

CINCINNATI - A Roman Catholic diocese in Ohio is discouraging its 113 schools from participating in the ice bucket challenge to benefit the ALS Association, saying the group's funding of embryonic stem cell research is "in direct conflict with Catholic teaching."

Jim Rigg, superintendent of Catholic schools for the Archdiocese of Cincinnati, told the schools in a letter Tuesday to "immediately cease" any plans to raise funds for the association and to instead direct donations to another organization that combats ALS, a progressive neurodegenerative disease also known as Lou Gehrig's disease that causes paralysis and almost certain death.

The Catholic Church relates the use of embryonic stem cells in research to abortion and says it violates the sanctity of human life. The use of adult stem cells in research is not forbidden by Catholic teaching.

"We certainly appreciate the compassion that has caused people all over the country, certainly including many Catholics, to be interacting and engaging in a fun way to support ALS research," diocese spokesman Dan Adriacco said Thursday. "But it's a well-established moral principle that not only the ends be good, but the means must be good, too."

Carrie Munk, a spokeswoman for the ALS Association, said her group largely funds adult stem cell research but does fund one study involving embryonic stem cells using money from one specific donor.

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Ohio diocese discourages ALS Association ice bucket challenge, cites embryonic stem cell funds

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