«The Department of Health and its Gene Therapy Advisory Committee are currently working with other regulators in the field to produce a «Regulatory Route Map» to provide further clarity on the regulatory requirements for
the clinical use of stem cells.»
Writing in the Transplantation, the researchers from Johns Hopkins Medical Institutions warned
clinical use of stem cells was still a long way off.
The ministry asked local health authorities to halt any unapproved
clinical use of stem cells in their regions.
Not exact matches
This includes a
stem cell research centre, a network
of drug discovery institutes and a # 20 million global
clinical development fund dedicated to supporting Phase I and II
clinical trials; and a # 2 million collaboration between University
of Cambridge and University College London that will
use donated
cells from people with Alzheimer's to test potential new treatments
Cord blood
stem cells can be
used to treat dozens
of diseases and are being tested in FDA - regulated
clinical trials to help people with autism, brain injury, and other conditions.
In addition, where
cells derived from embryonic
stem cells are great at proliferating — a potentially critical feature if one wants to grow sufficient numbers
of cells for
clinical use — ones from the iPS lines were much feebler.
Then, a team led by Robert Lanza, the chief scientific officer
of Advanced
Cell Technology Inc. in Marlborough, Massachusetts, and his colleagues published the first results ever
of a
clinical trial
using human embryonic
stem cells.
«We
used the algorithms to identify typical molecular signatures
of stem cells [stemness signatures] that could help us understand tumors and serve as predictors
of aggressiveness or
clinical outcome.»
The researchers reprogrammed the
cells to create induced pluripotent
stem cells in an FDA - compliant facility at the Broad Stem Cell Research Center; the use of this facility is an important step in the process as preclinical research moves toward human clinical tri
stem cells in an FDA - compliant facility at the Broad
Stem Cell Research Center; the use of this facility is an important step in the process as preclinical research moves toward human clinical tri
Stem Cell Research Center; the
use of this facility is an important step in the process as preclinical research moves toward human
clinical trials.
When isolated, 99 percent
of stem cells die, making it prohibitively difficult to manipulate their genes or expand their numbers for
clinical use.
An attempt by the Chinese health ministry to enforce a ban on the
clinical use of unapproved
stem -
cell treatments has had little effect
Using tumor samples from the Women's Healthy Eating and Living
clinical trial, researchers identified
stem - like tumor
cells as being characterized by low levels
of the molecule p53 upregulated modulator
of apoptosis (PUMA).
Despite a lack
of rigorous
clinical trials to test safety or efficacy, a ban
of the treatment by health authorities, and a lack
of peer review by the scientific community, the privately funded Stamina Foundation has been
using cultured mesenchymal
stem cells that have been exposed to putative conditions that favour neuronal differentiation to treat different diseases in severely or terminally ill patients.
«This shows not only that the
use of stem cell research in the
clinical treatment
of childlessness is unrealistic but also that clinics should focus on
using the eggs that women have had since birth in treating infertility,» says Professor Kui Liu.
They also summarise the outcome
of clinical trials that have investigated the
use of mesenchymal
stem cells in the treatment
of a number
of inflammatory, degenerative and immune - mediated diseases
of cats.
Lanza previously led a
clinical trial in the United States — published November 2014 in the Lancet — that demonstrated embryonic
stem cells could be
used safely for patients with degenerative eye diseases, but the patient sample was Caucasian with the exception
of one African - American.
Results from a
clinical trial investigating a new T
cell receptor (TCR) therapy that
uses a person's own immune system to recognize and destroy cancer
cells demonstrated a
clinical response in 80 percent
of multiple myeloma patients with advanced disease after undergoing autologous
stem cell transplants (ASCT).
In fact, in an ongoing
clinical trial that is transplanting
cells derived from induced pluripotent
stem cells (iPSCs), gene sequencing is
used to ensure the transplanted
cell products are free
of dangerous mutations.
Three months after the Chinese health ministry ramped up its efforts to enforce a ban on the
clinical use of unapproved
stem -
cell treatments, a Nature investigation reveals that businesses around the country are still charging patients thousands
of dollars for these unproven therapies.
«These splicing signatures could potentially be
used as
clinical biomarkers to detect blood
stem cells that show signs
of early aging or leukemia, and to monitor patient responses to treatment,» said Crews.
Carol Gillis, a longtime veterinarian and researcher who specializes in soft - tissue injuries in racehorses, says that the more than 22,000 ultrasound images she has captured in her studies and
clinical practice have convinced her that with a tightly regimented exercise program, tendons and ligaments will heal, producing strong, well - organized fibers — all without the
use of stem cells.
This feature would be critical for
clinical uses, such as transplanting
stem cells — with their defects corrected — back into patients, but the researchers emphasize that years
of further study remain before such treatments might be possible.
«This type
of analysis is likely to become a gold standard for quality controlling
stem cells, including induced pluripotent
stem cells, whether they are to be
used solely in research or envisioned for
clinical applications,» he says.
This will mark the start
of the first
clinical trial in China
using human embryonic
stem (ES)
cells, and the first one worldwide aimed at treating Parkinson's disease
using ES
cells from fertilized embryos.
Lorenz Studer, a
stem -
cell biologist at the Memorial Sloan Kettering Cancer Center in New York City who has spent years characterizing such neurons ahead
of his own planned
clinical trials, says that «support is not very strong» for the
use of precursor
cells.
The experiments will also represent the first
clinical trials
of ES
cells under regulations that China adopted in 2015, in an attempt to ensure the ethical and safe
use of stem cells in the clinic.
Fischer, in 2000, reported demonstrating the
clinical efficacy
of gene therapy for the first time,
using blood
stem cells to treat a fatal genetic disorder called X-linked severe combined immunodeficiency.
It has taken more than five years
of graft, but at long last approval has been given for the first
clinical trial
using human embryonic
stem cells (hESCs).
In the first published results from a
clinical trial
using human embryonic
stem cells, two legally blind patients who received an injection
of hESC - derived
cells in one eye have experienced no harmful side effects and appear to have slightly better vision.
More than 40
clinical trials are underway
using other kinds
of stem cells, mainly bone marrow
cells from the patients themselves.
Past
clinical trials
of stem cell therapies for chronic stroke patients
used cells derived from tumors in humans and brain tissue from fetal pigs.
This allows embryonic
stem cells to be employed as useful tools for both research and regenerative medicine, because they can produce limitless numbers
of themselves for continued research or
clinical use.
Paving the way for
stem cell therapy, the first
clinical trials
using iPSCs was conducted by Masayo Takahashi, MD, PhD,
of the RIKEN Centre for Developmental Biology in Japan.
Takashima K, Inoue Y, Tashiro S, Muto K. Lessons for reviewing
clinical trials
using induced pluripotent
stem cells: examining the case
of a first - in - human trial for age - related macular degeneration.
Her expertise includes optimization
of standard operating procedures for cGMP manufacture
of transgenic T
cells,
stem cells and dendritic
cells to be
used in
clinical trials, planning and writing
clinical trial protocols, IND (investigational new drug) applications and other regulatory documents.
Besides their
clinical use, we are interested in the biology
of hematapoietic
stem cells in - vitro and in - vivo.
Clinical studies have assessed have assessed fetal tissues as a therapeutic treatment for HD [2 - 4], although these present with problems which may be overcome by the
use of induced pluripotent
stem cells (iPSCs)[5].
The first eight projects target
clinical areas such as bone defects, salivary glands, and skin wounds
using a variety
of regenerative methods, such as
stem cells, biomaterial scaffolding, and harnessing regenerative signal secretion.
To better understand the range
of diseases being treated, I made a spreadsheet
of all the
clinical trials
using adipose
stem cells.
The birthday greeting contained an unintended irony, for while CIRM was approved by California voters a decade ago to give priority funding to human embryonic
stem cell research, eight
of the 10 approved
clinical trials referenced by City
of Hope were for research projects
using adult and other non-embryonic
stem cells.
To carry out pre-
clinical testing
of stem cell - derived mesDA and striatal GABAergic progenitors in rodent models
of PD and HD with the goal to generate efficient and safe candidate
cells for
clinical use;
By my count, a total
of 54
clinical trials
using adipose
stem cells have been registered with the clinicaltrials.gov database.
According to this excellent book on
stem -
cell biology, the volume
of stem -
cell research is now overwhelming, and the prospects for extended
clinical use are great.
While breast reconstruction
using adipose
stem cells has gotten a lot
of media attention because
of Suzanne Somers» experience, there are adipose
stem cell clinical trials ongoing for many diseases.
Based on positive results produced from a number
of scientific
clinical trials, coronary artery disease therapy
using adult
stem cells is a promising new method
of treatment for coronary artery disease patients.
The South Florida Bone Marrow /
Stem Cell Transplant Institute is now running a new
clinical trial protocol (08001 - BMSCTI) for investigating a novel cancer therapy
using transfusions
of white blood
cells from healthy donors.
Treating Spinal Cord Injuries: 2009 also saw the first FDA - approval
of the
use of human embryonic
stem cells in a
clinical trial.
Because the drug's mode
of action was known and patients» response to treatment could be precisely monitored, Michor and colleagues
used modeling methods and data from patients in a large
clinical trial to identify a group
of copiously self - renewing
stem cells, which persist within the tumor, resist the drug, and sustain the cancer.
The website is a perfect complement to the «
Stem Cells in Focus» blog, housing informational pages on basic stem cell biology, the process by which science becomes medicine, clinical trials and the use of stem cells in understanding and potentially treating specific health conditi
Stem Cells in Focus» blog, housing informational pages on basic stem cell biology, the process by which science becomes medicine, clinical trials and the use of stem cells in understanding and potentially treating specific health condit
Cells in Focus» blog, housing informational pages on basic
stem cell biology, the process by which science becomes medicine, clinical trials and the use of stem cells in understanding and potentially treating specific health conditi
stem cell biology, the process by which science becomes medicine,
clinical trials and the
use of stem cells in understanding and potentially treating specific health conditi
stem cells in understanding and potentially treating specific health condit
cells in understanding and potentially treating specific health conditions.
This type
of research will lead to a better understanding
of stem cell pluripotency and, ultimately,
clinical use.