Stem Cell Clinic

AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury

BURLINGTON, Mass.--(BUSINESS WIRE)--

AlloCure, Inc. today announced that it has initiated a phase 2 clinical trial of AC607, the companys mesenchymal stem cell therapy, as a potential treatment for acute kidney injury (AKI). The randomized, double-blind, placebo-controlled, multi-center trial, designated ACT-AKI (AC607 Trial in Acute Kidney Injury) (NCT01602328), will enroll 200 cardiac surgery subjects at leading tertiary care centers in the United States.

ACT-AKI follows the positive results from a phase 1 AC607 trial in cardiac surgery subjects, which showed an excellent safety profile and encouraging data on the incidence of AKI and hospital length of stay, said Robert M. Brenner, M.D., AlloCure President and Chief Executive Officer. We have worked closely with leaders in the field on the design of ACT-AKI, and trial initiation represents an important milestone for AlloCure and the patients we collectively serve.

AC607 is a promising therapeutic candidate for AKI, for which effective therapies are greatly needed, said Richard J. Glassock, M.D., Emeritus Professor of Medicine at the Geffen School of Medicine at the University of California, Los Angeles. The initiation of ACT-AKI represents a critical step in the development of an innovative therapy for this all-too-common, serious and costly medical condition, for which no approved treatments currently exist beyond supportive care.

About AC607

AC607 is a novel biologic therapy under development for the treatment of AKI. AC607 also possesses potential applications in other grievous illnesses. AC607 comprises allogeneic bone marrow-derived mesenchymal stem cells that are harvested from healthy adult donors and then expanded via a mature and state-of-the art manufacturing process. AC607 homes to the site of injury where it mediates powerful anti-inflammatory and organ repair processes via the secretion of beneficial paracrine factors, without differentiation and repopulation of the injured kidney. Importantly, AC607 avoids recognition by the hosts immune system, enabling administration in an off the shelf paradigm without the need for blood or tissue typing.

About AlloCure

AlloCure, Inc. is a privately held, clinical-stage biotechnology company focused on the treatment of kidney disease. The company is a leader in the AKI field and is pioneering the development of the first effective therapy for the treatment of AKI. The companys headquarters is located in Burlington, MA. For more information about AlloCure, please visit the companys web site at http://www.allocure.com.

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AlloCure Begins Phase 2 Clinical Trial in Acute Kidney Injury

Cellerant Awarded $36.4 Million Option under Existing U.S. Government Contract to Support Development of CLT-008 for …

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded $36.4 million under an option exercised by the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services, for the advanced development of CLT-008, a first-in-class, allogeneic, cell-based therapy for the treatment of Acute Radiation Syndrome (ARS). This third year of funding is in addition to the $80 million committed under the two-year base period and is part of a five-year award valued at up to $169.9 million.

This additional funding will continue to support Cellerants CLT-008 development strategy by providing funds for its ongoing clinical trials, process development and manufacturing activities and the nonclinical studies required for approval in ARS. If licensed by the U.S. Food and Drug Administration (FDA), the federal government could buy CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.

We are pleased that the federal government continues to support our biodefense efforts to advance CLT-008, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. Our collaboration with BARDA over the past two years has been productive and this option exercise demonstrates BARDAs continued endorsement and satisfaction with the development and progress of CLT-008 as a potential medical countermeasure.

As part of BARDAs commitment to supporting multi-use products that have both commercial and biodefense applications, this third year of funding also allows Cellerant to continue its ongoing clinical trials with CLT-008 for cancer applications. Cellerants first Phase 1 study is evaluating CLT-008 in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. Cellerants second Phase 1/2 study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia. CLT-008 may shorten the time to neutrophil recovery and decrease the risks of febrile neutropenia and infection.

In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation such as from a nuclear or radiological weapon, or from a nuclear accident. Various preclinical studies conducted to date suggest that a single dose of CLT-008 could provide effective treatment for ARS in an emergency situation, and could be administered up to five days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administrations Animal Efficacy Rule for ARS. This approval pathway requires demonstration of efficacy in representative animal models and safety and metabolism testing in human clinical trials. There is currently no FDA approved medical countermeasure to treat ARS.

About CLT-008

CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human myeloid progenitor cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, cryopreserved, allogeneic mouse myeloid progenitor cells have been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficacy. Cellerant is developing CLT-008 as a treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.

About Cellerant Therapeutics

Cellerant Therapeutics is a clinical stage biotechnology company focused on the regulation of the hematopoietic (blood-forming) system. The Company is developing human stem cell and antibody therapies for oncology applications and blood-related disorders. Cellerants lead product, CLT-008, is currently in two Phase 1 clinical trials in patients with hematological malignancies. The Company also has a cancer stem cell (CSC) antibody discovery program focused on therapies for acute myelogenous leukemia, multiple myeloma and myelodysplastic syndrome.

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Cellerant Awarded $36.4 Million Option under Existing U.S. Government Contract to Support Development of CLT-008 for ...

Stem cell jab

By Daily Mail Reporter

PUBLISHED: 12:03 EST, 4 September 2012 | UPDATED: 12:03 EST, 4 September 2012

Patients with broken spines have reported having feeling restored to areas that had previously been paralysed, after receiving stem cell injections.

Scientists said they were 'encouraged' after two of three patients injected with donated foetal brain tissue responded to treatment at Balgrist University Hospital in Zurich, Switzerland.

Each patient had around 20million neural stem cells delivered directly into their injured spinal cords between four and eight months after they were injured.

Early tests suggest stem cells could restore feeling to people with damaged spinal cords

Before the treatment none of the patients could feel anything below the nipples. Just three months after therapy two of the patients reported feeling some sensation. By six months they could detect both touch and heat between the chest and belly button. The third patient detected no changes.

Stephen Huhn, vice president of StemCells in Newark, California, that is developing the treatment told the New Scientist: 'The face we've seen responses to light touch, heat and electrical impulses so far down in two of the patients is very unexpected.

'They're really close to normal in those areas now in their sensitivity.'

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Stem cell jab

First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in …

SEOUL, South Korea, Sept. 4, 2012 /PRNewswire/ --Korean researchers, reporting the results of a major study in the Circulation Journal, found that the transplantation adipose (fat) derived stem cells resulted in the regeneration of blood vessels in patients who were otherwise expecting to receive limb amputations due to damaged arteries and lack of blood circulation.

Researchers at Pusan National University, led by Dr. Han Cheol Lee, describe how patients with critical limb ischemia (hereafter, CLI, example of which include Buerger's Disease and diabetic foot ulcers) were injected with adipose tissue-derived mesenchymal stem cell manufactured by RNL BIO.

As a result of the remarkable adipose stem cell process of RNL BIO, researchers found that immediate new blood vessel generation was identified. (The title of article is "Safety and Effect of Adipose Tissue-Derived Stem Cell Implantation in Patients With Critical Limb Ischemia")

CLI results from lack of circulation due to small artery damage and subsequent tissue necrosis. Patients with severe CLI often face limb amputation. Buerger's Disease, or diabetic foot ulcer, are of the same kind. Risk factors are diabetic mellitus, hypertension, high cholesterol and smoking. There is no known cure to date.

Currently percutaneous transluminal angioplasty or PTA may treat 60-70% of patients with CLI, but it doesn't work with those who suffer from Buerger's Disease. Working under approval to conduct compassionate use research of stem cell to treat CLI by intra-muscular injection of adipose tissue derived stem cells in December, 2008 (KFDA IND approval # 1273), the researchers in this study enrolled 15 subjects: 12 with Buerger's Disease, and 3 with Diabetic foot ulcers. 300 million stem cells were injected into each patient's leg. No complications were observed, even six months after injection.

Only five patients, as they all had expected, required minor amputation during follow-up, and all amputation sites healed completely. At 6 months, significant improvement was noted in pain and in claudication walking distance. Digital subtraction angiography before and 6 months after ATMSC implantation showed formation of numerous vascular collateral networks across affected arteries.

Dr. Jeong-Chan Ra, President of RNL Stem Cell Technology Institute, said, "This new therapy through adipose tissue derived mesenchymal stem cell is expected to offer new hope for patients with CLI, hope that had been difficult to find before."

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First Evidence that Adipose Stem Cell-Based Critical Limb Ischemia Treatment is Safe & Effective is published in ...

Global Human Embryonic Stem Cell (hESC) Research Industry

NEW YORK, Sept. 3, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Global Human Embryonic Stem Cell (hESC) Research Industry

http://www.reportlinker.com/p0960425/Global-Human-Embryonic-Stem-Cell-hESC-Research-Industry.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biological_Therapy

This report analyzes the worldwide markets for Human Embryonic Stem Cell (hESC) Research in US$ Million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2018. The report profiles 26 companies including many key and niche players such as Advanced Cell Technology, Inc., BD Biosciences, BioTime, Inc., Cell Cure Neurosciences Ltd., Cellartis AB, GE Healthcare, Millipore Corporation, Molecular Transfer, Inc., PerkinElmer, Inc., Pfizer, Inc., Research & Diagnostics Systems, Inc., Reliance Life Sciences Ltd., Stem Cell Network, Stemina Biomarker Discovery, Inc., UK Stem Cell Bank, and ViaCyte, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1

Disclaimers I-2

Data Interpretation & Reporting Level I-2

Quantitative Techniques & Analytics I-3

Product Definitions and Scope of Study I-3

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Global Human Embryonic Stem Cell (hESC) Research Industry

Stem cells bring back feeling for paralysed patients

For the first time, people with broken spines have recovered feeling in previously paralysed areas after receiving injections of neural stem cells.

Three people with paralysis received injections of 20 million neural stem cells directly into the injured region of their spinal cord. The cells, acquired from donated fetal brain tissue, were injected between four and eight months after the injuries happened. The patients also received a temporary course of immunosuppressive drugs to limit rejection of the cells.

None of the three felt any sensation below their nipples before the treatment. Six months after therapy, two of them had sensations of touch and heat between their chest and belly button. The third patient has not seen any change.

"The fact we've seen responses to light touch, heat and electrical impulses so far down in two of the patients is very unexpected," says Stephen Huhn of StemCells, the company in Newark, California, developing and testing the treatment. "They're really close to normal in those areas now in their sensitivity," he adds.

"We are very intrigued to see that patients have gained considerable sensory function," says Armin Curt of Balgrist University Hospital in Zurich, Switzerland, where the patients were treated, and principal investigator in the trial.

The data are preliminary, but "these sensory changes suggest that the cells may be positively impacting recovery", says Curt, who presented the results today in London at the annual meeting of the International Spinal Cord Society.

The patients are the first three of 12 who will eventually receive the therapy. The remaining recipients will have less extensive paralysis.

"The sensory gains, first detected at three months post-transplant, have now persisted and evolved at six months after transplantation," says Huhn. "We clearly need to collect much more data to demonstrate efficacy, but our results so far provide a strong rationale to persevere with the clinical development of our stem cells for spinal injury," he says.

"We need to keep monitoring these patients to see if feeling continues to affect lower segments of their bodies," says Huhn. "These are results after only six months, and we will follow these patients for many years."

Huhn says that the company has "compelling data" from animal studies that the donated cells can repair nerves within broken spines (Neurological Research, DOI: 10.1179/016164106X115116).

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Stem cells bring back feeling for paralysed patients

Newly identified stem cell population in skin's epidermis responsible for tissue repair

ScienceDaily (Sep. 3, 2012) Researchers at the Universit Libre de Bruxelles, ULB identify a new stem cell population in the skin epidermis responsible for tissue repair.

The skin, which is an essential barrier that protects our body against the external environment, undergoes constant turnover throughout life to replace dead cells that are constantly sloughed off from the skin surface. During adult life, the number of cells produced must exactly compensate the number of cells lost. Different theories have been proposed to explain how this delicate balance is achieved.

In a new study published in Nature, researchers lead by Pr. Cdric Blanpain, MD/PhD, FNRS/FRS researcher and WELBIO investigator at the IRIBHM, Universit libre de Bruxelles, Belgium, in collaboration with Pr. Benjamin Simons, University of Cambridge, UK, demonstrate the existence of a new population of stem cells that give rise to progenitor cells that ensure the daily maintenance of the epidermis and demonstrate the major contribution of epidermal stem cells during wound healing.

In this new study, Guilhem Mascr and colleagues used novel genetic lineage tracing experiments to fluorescently mark two distinct epidermal cell populations, and follow their survival and contribution to the maintenance of the epidermis overtime. Interestingly, in doing so, they uncover the existence of two types of dividing cells. One population of proliferative cells presented a very long term survival potential while the other population is progessively lost overtime. In collaboration with Pr. Benjamin D. Simons, the authors developed a mathematical model of their lineage tracing analysis. The authors proposed that the skin epidermis is hierarchically organized with slow cycling stem cells residing on the top of the cellular hierarchy that give rise to more rapidly cycling progenitor cells that ensure the daily maintenance of the skin epidermis. Analysis of cell proliferation confirms the existence of slow cycling stem cells and gene profiling experiments demonstrate that the stem and the progenitors cells are characterized by distinct gene expression.

Importantly, by assessing the contribution these two populations of cells during wound healing, they found that only stem cells are capable of extensive tissue regeneration and undergo major expansion during this repair process, while the progenitors did not expand significantly, and only provide a short-lived contribution to the wound healing response. As well as resolving the cellular hierarchy of epidermis, this is the first demonstration of a critical role of epidermal SC during wound healing. "It was amazing to see these long trails of cells coming from a single stem cell located at a very long distance from the wound to repair the epidermis" comments Cdric Blanpain, the senior author of this study.

In conclusion, this work demonstrates the existence of slow-cycling stem cells that promote tissue repair and more rapidly cycling progenitors that ensure the daily maintenance of the epidermis. A similar population of slow cycling stem cells that can be rapidly mobilized in case of sudden need has been observed in other tissues, such as the blood, muscle and hair follicle, and the partition between rapidly cycling progenitors and slow cycling stem cells could be relatively conserved across the different tissues. This study may have important implications in regenerative medicine in particular for skin repair in severely burnt patients or in chronic wounds.

This work was supported by the FNRS, the " Brain back to Brussels " program from the Brussels Region, the program d'excellence CIBLES of the Wallonia Region, a research grant from the Fondation Contre le Cancer, the ULB foundation, the fond Gaston Ithier. Cdric Blanpain is an investigator of WELBIO and is supported by a starting grant of the European Research Council (ERC) and the EMBO Young Investigator Program.

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Newly identified stem cell population in skin's epidermis responsible for tissue repair

Paralyzed patients regain some sensory function after neural stem cell treatment

StemCells' human neural stem cell

But, promising new research from a phase 1 study conducted at the University of Zurich sponsored by StemCells, Inc. shows that six months after the implantation of neural stem cells, two out of three complete injury patients - meaning they had no neurological function below the point of injury - were able to gain some sensory function.

"We haven't made progress in how to address injury after they occur, but using neural stem cells in a transplant lets us, for the first time, think we can repair this," Dr. Stephen Huhn, a neurosurgeon and the vice president and head of the CNS program at StemCells, Inc. said to HealthPop.

The phase 1 study was intended to see if the implantation treatment had any unwanted side effects. For the procedure, 20 million neural stem cells were implanted directly into the spinal cord, something that has never been done before. Then, any reactions were monitored including complex examinations of sensory function - for example light touch, sensitivity to temperature and sensitivity to subtle electronic stimulation - as well as electrostimulation of the spinal cord itself.

What researchers were surprised to find was that the neural stem cell implantation was able to return some sensation to these paralyzed patients, who were all injured at the thoracic or chest level.

Hugh explained that if you think of the spinal cord and its 31 segments as a building with a series of floors, these patients could not access the floor below the point of the initial trauma. However, after the implantation, one patient was able to access three to four floors (or spinal cord segments below the paralysis point) and the other was able to reach five or six floors.

"These patients have had such an injury to their spinal cord that to see this kind of effect is amazing. They contain the worst of the worst injuries," he explained.

While the other patient did not regain sensation, none of the patients had any negative side effects. Huhn believes this means that the treatment may be able to work even better for people who have limited function after a traumatic injury. Since the treatment has been deemed to be safe, the next phase is to test the implantation on nine other people who have incomplete injuries or some limited sensation or function after an injury.

Huhn recognizes that the field of stem cell research is controversial. The world's only other trial using stem cells to treat spinal injury - which used embryonic stem cells - was ended in 2011 for financial reasons, according to the New Scientist. But, Huhn feels that the unique properties of neural stem cells and potential benefits warrant their use in medical treatment. Neural stem cells have the unique ability to divide and replicate themselves though cell culture. This means that for this trial, the team was able to use only one donated brain source to supply all the material needed for the study.

"This is a very delicate area, and we appreciate that neural stem cells are one of the first discoveries that we've had in which we can think about biologically repairing the nervous system," "Now we have a tool, a technology - something we can think about repairing the central nervous system with."

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Paralyzed patients regain some sensory function after neural stem cell treatment

Annabelle Rama to undergo stem cell treatment to improve health

YAHOO:

Talent manager Annabelle Rama will fly to Germany in September to undergo therapy - stem cell therapy, that is. This has been a promise made by her son Richard Gutierrez who's footing the bill. "Early this year pa lang ay napagplanuhan na 'yung pagpapa-stem cell ng nanay ko at prinomise ko sa kanya na pag-iipunan ko, prinomise ko sa kanya na ako ang magti-treat sa kanya," Richard said on the first episode of "H.O.T. TV," Aug. 5.

He noted, "'Yung mom ko hindi mahilig 'yan na pumunta sa mga doctor, hindi mahilig magpa-check-up."

Looking forward

This early, Annabelle is already excited about her trip and the upcoming treatment.

"Kaya ako excited pumunta kasi unang-una mataas ang aking sugar, mataas ang aking cholesterol, tapos me problema pa ako sa high blood, blood pressure ko. Siguro nga kailangan kong pumunta ng Germany," she said, noting that the condition of her friends, talent manager Lolit Solis and actress Lorna Tolentino, have improved tremendously after going through stem cell therapy.

"Nakita ko ang mukha ni Lolis pumuputi ang mukha niya, eh at saka mukha siyang fresh na fresh. Lalo na si LT, nakita ko rin siya. Mukhang gumanda naman siya. Basta lahat ng kaibigan kong galing doon, nakakausap ko, sabi nila ay talagang gumaling daw sila. 'Yung kanilang napi-feel na mabigat sa katawan dahil sa sakit nila ay nawawala lahat," she said.

Exorbitant fees?

Annabelle had already inquired about the fees of stem cell procedure in the country and she feels it's exorbitant.

"Kasi sa Piipinas may pinagtatanungan na ako, umabot ng mga four million pesos 'yung naitanong ko kaya parang na-discourage akong magpagamot kasi nga ganoon kamahal."

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Annabelle Rama to undergo stem cell treatment to improve health

Lorna Tolentino underwent stem cell treatment to improve health

PEP:

Kahit pa noong kabataan niya ay kilala na si Lorna Tolentino bilang isa sa may pinakamagandang mukha sa Philippine showbiz industry. Hanggang ngayon na edad 50 na siya ay wala pa rin itong kupas.

Ang kanyang sikreto ay nasa patuloy na pangangalaga niya sa katawan.

Mahilig mag-ehersisyo si Lorna, at ilan sa regular niyang ginagawa ay ang yoga at gym workout. Nagda-diet din siya upang suportahan ang pag-e-exercise.

Halos lahat na ng diet ay napagdaanan ko na, pero ang tamang paraan pa rin ay mag-ehersisyo ka at [kumain ng] tamang pagkain, saad ng aktres sa panayam ng PEP (Philippine Entertainment Portal), noong July 17 sa TV5 event sa Elements Centris, Quezon City.

Ibig sabihin, meron pa ring caution akong ginagawa. Binabantayan ko rin kung ano yung kinakain ko kasi sabi nga nila, You are what you eat, e.

Mas mapili ngayon si Lorna sa kanyang mga kinakain dahil na rin sa kanyang bad cholesterol level at hormonal imbalance sa katawan.

Hindi siya kumakain ng anumang matataba at maalat na pagkain.

Pagdating naman sa kanyang balat, Siyempre sa pangangalaga ng Flawless at Belo, at ni Joey Santos ng Villa Medica, kaya heto, patuloy na maganda yung skin ko.

STEM CELL TREATMENT. Bukod sa kanyang panlabas na anyo ay pinangangalagaan din nang husto ni Lorna ang kanyang kalusugan.

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Lorna Tolentino underwent stem cell treatment to improve health