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Category Archives: Stem Cell Human Trials

Stem Cell FAQ

Posted: October 19, 2015 at 6:41 am

Some of the promise of stem cell therapy has been realized. A prime example is bone marrow transplantation. Even here, however, manyproblems remain to be solved. Challenges facing stem cell therapy include the following: Adult stem cells Tissue-specific stem cells in adult individuals tend to be rare. Furthermore, while they can regenerate themselves in an animal or person they are generally very difficult to grow and to expand in the laboratory. Because of this, it is difficult to obtain sufficient numbers of many adult stem cell types for study and clinical use. Hematopoietic or blood-forming stem cells in the bone marrow, for example, only make up one in a hundred thousand cells of the bone marrow. They can be isolated, but can only be expanded a very limited amount in the laboratory. Fortunately, large numbers of whole bone marrow cells can be isolated and administered for the treatment for a variety of diseases of the blood. Skin stem cells can be expanded however, and are used to treat burns. For other types of stem cells, such as mesenchymal stem cells, some success has been achieved in expanding the cellsin vitro, but application in animals has been difficult. One major problem … Continue reading

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Ready or Not: Stem Cell Therapies Poised to Enter Trials …

Posted: October 12, 2015 at 11:44 am

20 Nov 2014 Stem cells have been hailed, and hailed some more, as a breakthrough technology. All the same, they have been slow to make real inroads in the understanding and treatment of Alzheimers disease. That is about to change, according to scientists who spoke at Accelerating the Cure for Alzheimers Disease through Regenerative Medicine. Held November 6 at Duke University, Durham, North Carolina, the symposium was co-chaired by Murali Doraiswamy and Joanne Kurtzberg. Kurtzberg is a pediatrician and cell therapy expert atDuke. The first clinical trials of stem cells for AD are expected to begin in 2015, speakers said. Some cautioned that many questions remain about how stem cells affect the Alzheimers brain. They debated whether the move into the clinic is premature, noting the need for more research into where in the brain stem cells go and how long they last. On this, attendees were intrigued by some success tracking injected cells with MRI. In addition to therapeutic applications, induced stem cells made from patients with AD and related disorders are helping shed light on disease mechanisms and enabling screens for potentially therapeutic compounds. Research on stem cells remains limited, however, in part because it is largely supported … Continue reading

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Cell Trials

Posted: October 1, 2015 at 3:42 pm

Starting from 2014, I was trying to capture results of clinical studies in cell therapy. Today, Id like to share some results of this attempt. I decided to narrow down my analysis to regenerative medicine, since most of cell-based therapies with published results belong to this category. Inclusion criteria and definitions Exclusion criteria Search strategy I set very loose filter for search of clinical studies results by using PubMed database with query stem cell. I receive notifications about new publications from this query via RSS feed. Stem cell query captures about 50-100 publications daily, 90% of clinical studies. Total number of studies and data capture Demographics A great variety of countries published results of clinical studies in 2014. The biggest number of reports came from China. US was the second biggest contributor. I summarized major contributing countries (more than 4 reports) in this figure: Cell types As one may predict, Mesenchymal Stromal Cells (MSC) was the major cell type (35%) in cell-based regenerative medicine clinical studies. Mobilized hematopoietic stem/progenitor cells (HPC-A) and bone marrow mononuclear cells (BM MNC) were another popular type of cells for tissue regeneration. Interestingly, 2 reports were about results of studies, involved embryonic stem cell-based (ESC) … Continue reading

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UK scientists start stem cell trial of potential blindness …

Posted: September 29, 2015 at 1:41 am

LONDON The first patient has been treated in Britain in a pioneering trial of a new treatment co-developed by Pfizer and derived from embryonic stem cells designed for patients with a condition that can cause blindness. Specialists at London's Moorfields Eye Hospital said the operation, described as "successful", was the first of 10 planned for participants in a trial of the treatment for a disease called 'wet' age-related macular degeneration (AMD). The trial will test the safety and efficacy of transplanting eye cells known as retinal pigment epithelium, which have been derived from embryonic stem cells. Stem cells are the body's master cells, the source of all other cells. Scientists who support the use of embryonic stem cells say they could transform medicine, providing treatments for blindness, juvenile diabetes or severe injuries. But critics object to them because they are harvested from human embryos. This trial involves surgeons inserting a specially engineered patch behind the retina to deliver the treatment cells to replace diseased cells at the back of the eye. The first surgery was successfully performed on a patient last month, Moorfields said in a statement on Tuesday, and "there have been no complications to date". "The patient wishes … Continue reading

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All Things Stem Cell Visual Stem Cell Glossary

Posted: September 27, 2015 at 1:44 am

Stem cells: Cells that are able to (1) self-renew (can create more stem cells indefinitely) and (2) differentiate into (become) specialized, mature cell types. Embryonic stem cells: Stem cells that are harvested from a blastocyst. These cells are pluripotent, meaning they can differentiate into cells from all three germ layers. Embryonic stem cells are isolated from cells in a blastocyst, a very early stage embryo. Once isolated from the blastocyst, these cells form colonies in culture (closely packed groups of cells) and can become cells of the three germ layers, which later make up the adult body. Adult stem cells (or Somatic Stem Cell): Stem cells that are harvested from tissues in an adult body. These cells are usually multipotent, meaning they can differentiate into cells from some, but not all, of the three germ layers. They are thought to act to repair and regenerate the tissue in which they are found in, but usually they can differentiate into cells of completely different tissue types. Adult stem cells can be found in a wide variety of tissues throughout the body; shown here are only a few examples. The Three Germ Layers: These are three different tissue types that exist during … Continue reading

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Stem Cell Basics: Potential uses of human stem cells

Posted: September 17, 2015 at 6:41 am

There are many ways in which human stem cells can be used in research and the clinic. Studies of human embryonic stem cells will yield information about the complex events that occur during human development. A primary goal of this work is to identify how undifferentiated stem cells become the differentiated cells that form the tissues and organs. Scientists know that turning genes on and off is central to this process. Some of the most serious medical conditions, such as cancer and birth defects, are due to abnormal cell division and differentiation. A more complete understanding of the genetic and molecular controls of these processes may yield information about how such diseases arise and suggest new strategies for therapy. Predictably controlling cell proliferation and differentiation requires additional basic research on the molecular and genetic signals that regulate cell division and specialization. While recent developments with iPS cells suggest some of the specific factors that may be involved, techniques must be devised to introduce these factors safely into the cells and control the processes that are induced by these factors. Human stem cells are currently being used to test new drugs. New medications are tested for safety on differentiated cells generated … Continue reading

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Human neural stem cell transplantation in ALS: initial …

Posted: September 13, 2015 at 8:46 pm

Abstract Background We report the initial results from a phase I clinical trial for ALS. We transplanted GMP-grade, fetal human neural stem cells from natural in utero death (hNSCs) into the anterior horns of the spinal cord to test for the safety of both cells and neurosurgical procedures in these patients. The trial was approved by the Istituto Superiore di Sanit and the competent Ethics Committees and was monitored by an external Safety Board. Six non-ambulatory patients were treated. Three of them received 3 unilateral hNSCs microinjections into the lumbar cord tract, while the remaining ones received bilateral (n=3+3) microinjections. None manifested severe adverse events related to the treatment, even though nearly 5 times more cells were injected in the patients receiving bilateral implants and a much milder immune-suppression regimen was used as compared to previous trials. No increase of disease progression due to the treatment was observed for up to18 months after surgery. Rather, two patients showed a transitory improvement of the subscore ambulation on the ALS-FRS-R scale (from 1 to 2). A third patient showed improvement of the MRC score for tibialis anterior, which persisted for as long as 7months. The latter and two additional patients refused PEG … Continue reading

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From stem cells to billions of human insulin-producing …

Posted: August 19, 2015 at 2:45 pm

Harvard stem cell researchers today announced that they have made a giant leap forward in the quest to find a truly effective treatment for type 1 diabetes, a condition that affects an estimated 3 million Americans at a cost of about $15 billion annually: With human embryonic stem cells as a starting point, the scientists are for the first time able to produce, in the kind of massive quantities needed for cell transplantation and pharmaceutical purposes, human insulin-producing beta cells equivalent in most every way to normally functioning beta cells. Doug Melton, who led the work and who 23 years ago, when his then infant son Sam was diagnosed with type 1 diabetes, dedicated his career to finding a cure for the disease, said he hopes to have human transplantation trials using the cells to be underway within a few years. We are now just one pre-clinical step away from the finish line, said Melton, whose daughter Emma also has type 1 diabetes. A report on the new work has today been published by the journal Cell. Felicia W. Pagliuca, Jeff Millman, and Mads Gurtler of Meltons lab are co-first authors on the Cell paper. The research group and paper … Continue reading

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Why I'm sure human stem cell trial will be safe – New …

Posted: August 9, 2015 at 6:45 pm

(Image: Natasha Little) The new kind of stem cell announced yesterday may be the future of regenerative medicine, but Masayo Takahashis pilot safety study using a type of stem cell to treat age-related blindness is at the cutting edge Later this year, you will make history when you begin the first ever human trial of induced pluripotent stem cells. Why is this such a big deal? Stem cells have enormous medical potential because they can become any other type of cell. If we can use them to replace old or damaged cells, this could have huge implications for treating degenerative diseases. Stem cells can be harvested from embryos, but this is ethically controversial. Despite this, there are several trials of these embryonic stem cells under way. Their use often requires drugs to stop the immune system from rejecting them, which can cause complications for elderly patients. Induced pluripotent stem (iPS) cells offer an alternative. These are made from a patients own cells, removing the need for the immunosuppressant drugs. Plus there are no ethical issues. How would treatment with iPS cells work? iPS cells are made by injecting several reprogramming genes into adult cells that have been removed from the … Continue reading

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Stem Cell Trial ALS Clinic

Posted: August 1, 2015 at 10:40 am

Stem cell transplantation study for the treatment of ALS Phase 2 The phase 2 trial focused on the safety and maximum tolerated dose of Human Spinal Cord Derived Neural Stem Cell Transplantation. This study expanded on the work of the phase 1 study directed by Eva L. Feldman, M.D., Ph.D., who is the principal investigator and director of the first-ever FDA-approved human clinical trial of stem cells injected directly into the spinal cords of ALS patients. Phase 1 of the trial, designed to study the safety of the procedure, was completed in 2013 with no significant adverse side effects to patients. And follow-up patient evaluations have produced some extraordinary data: Several participants in the trial, who were treated early in their disease, were determined to have had little or no significant progression of ALS for more than 700 days post-surgery. Updated July 2015: Fifteen patients were studied in the phase 2 study, the last 3 of which received 8 million stem cells injected into the lumbar spinal cord followed by 8 million stem cells injected into the cervical spinal cord. All procedures have been completed and the trial is still ongoing. No data has been released. https://clinicaltrials.gov/show/NCT01730716 Future trials Updated … Continue reading

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We cordially invite you to collaborate with us (as Speaker/Exhibitor/Sponsor/Media Partner) for “10th Annual Conference on Stem Cell and Regenerative Medicine” scheduled on August 13-14, 2018 in London, UK.

For meeting details visit: https://stemcell-regenerativemedicine.conferenceseries.com/