Meeting scalability challenges
for autologous cell - based manufacturing with automated closed - system solutions
«If we win, the entire regulatory structure
for autologous cell processing, with or without culture, will be rewritten such that any physician using good practices and treating patients responsibly can use stem cells as part of his or her medical practice,» he says.
Not exact matches
This may entail making small holes in the bone to allow new cartilage to grow (microfracture), taking cartilage from another part of the athlete's knee and transplanting it into the defect (osteochondral autograft transfer), taking cartilage
cells from the knee and then having them grown in a lab
for later re-implantation (
autologous chondrocyte implantation), or taking cartilage from a person who has passed away and placing it in the defect (osteochondral allograft transfer).
«I'm working with Professor Richard Oreffo and Dr Rahul Tare from the University's Centre
for Human Development, Stem
Cells and Regeneration who are trying to create and grow cartilage in the lab using a patients» own (autologous) stem cells to then be implanted back into the patient if they have a cartilage defect,» she expl
Cells and Regeneration who are trying to create and grow cartilage in the lab using a patients» own (
autologous) stem
cells to then be implanted back into the patient if they have a cartilage defect,» she expl
cells to then be implanted back into the patient if they have a cartilage defect,» she explains.
While some previous studies found that maintenance lenalidomide after
autologous hematopoietic stem
cell transplant improved overall survival
for newly diagnosed multiple myeloma patients, others showed no benefit to this approach.
For this analysis, 605 patients with newly diagnosed multiple myeloma and treated with continuous lenalidomide (brand name Revlimid) following
autologous stem
cell transplant were compared to 604 patients who were treated with placebo or no maintenance.
«Lenalidomide maintenance following
autologous stem
cell transplant can now be considered a standard of care
for people with multiple myeloma,» says Dr. McCarthy, senior author on the meta - analysis and Principal Investigator of the U.S. study, CALGB (Alliance) 100104.
Autologous hematopoietic stem
cell transplantation (AHSCT) has been investigated as a treatment
for aggressive MS, the rationale
for which is immune reconstitution.
HSCT is effectively used today as a form of «replacement» therapy
for patients with hard - to - treat blood cancers, providing healthy
cells from either the patient (
autologous transplantation) or from a donor (allogeneic transplantation) to better equip patients to fight the disease on their own.
In particular, they allege that news of the investigations, which came to light this past April, cost them millions of dollars by derailing a deal to sell their stem
cell company,
Autologous / Progenital, and took them out of the running
for lucrative faculty positions.
Among the new tests Cowan expects will be ready in time
for the games are a more accurate test
for human growth hormone (HGH) and a test
for autologous blood doping, a method athletes use to boost the number of red blood
cells and oxygen in circulation by drawing their own blood, storing it, and then transfusing it back into themselves.
«These findings give a rationale to start
autologous transplantation — at least of neural
cells — in clinical situations,» says senior author Dr. Jun Takahashi, of the Kyoto University's Center
for iPS
Cell Research and Application.
«Previous studies have shown that a threshold percentage of limbal stem
cells (which are responsible
for replenishing the cornea) is required
for successful corneal
autologous therapy,» says co-first author Tom Bongiorno, a graduate student in bioengineering at Georgia Tech.
Dr. Henry presented «Final Results
for THE ATHENA TRIALS:
Autologous Adipose Derived Regenerative
Cells (ADRCs)
for Refractory Chronic Myocardial Ischemia with Left Ventricular (LV) Dysfunction» on Thursday, May 5, 2016 at 11:00 a.m. ET.
The therapy is approved by the U.S. Food and Drug Administration
for relapsed or treatment - resistant Hodgkin lymphoma, and it is commonly prescribed to patients whose disease has progressed after
autologous stem
cell transplant, a procedure that replenishes the bone marrow with the patient's own healthy stem
cells after therapy.
«
Autologous stem cell transplant should be standard care for HIV - associated lymphoma: Multicenter, Phase II trial suggests autologous transplant should be standard of care for HIV patients with relapsed / treatment - resistant lympho
Autologous stem
cell transplant should be standard care
for HIV - associated lymphoma: Multicenter, Phase II trial suggests
autologous transplant should be standard of care for HIV patients with relapsed / treatment - resistant lympho
autologous transplant should be standard of care
for HIV patients with relapsed / treatment - resistant lymphoma.»
«This work has the potential to provide a novel source of abundant, easily accessible and
autologous cells for treatment of devastating neurodegenerative diseases.
Based on our data,
autologous stem
cell transplant should be considered the standard of care
for patients with HIV - related lymphomas
for the same indications and under the same circumstances that we would use it in patients without HIV infection.»
A national study on conditional survival, excess mortality and second cancer after high dose therapy with
autologous stem
cell transplantation
for non-Hodgkin lymphoma.
Conditional survival and excess mortality after high - dose therapy with
autologous stem
cell transplantation
for adult refractory or relapsed Hodgkin lymphoma in Norway.
Other researchers at Joslin are conducting large scale genetic screening
for novel therapeutic targets to control autoimmunity, which will complement the effort of BAIRT to extend
autologous beta
cell replacement to patients with type 1 diabetes.
Vision Loss after Intravitreal Injection of
Autologous «Stem
Cells»
for AMD.
Cloning of the gene coding
for a shared human melanoma antigen recognized by
autologous T
cells infiltrating into tumor.
Plerixafor has been approved by the FDA as the first small - molecule CXCR4 antagonist
for use in combination with granulocyte - colony stimulating factor (GCSF) to mobilize hematopoietic stem
cells to the bloodstream
for collection and subsequent
autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma.
We published the first experience with double
autologous peripheral blood stem
cell transplant
for high - risk neuroblastoma.
Anke Theil (Bonifacio, TUD)-- «Exploring the therapeutic potential of
autologous cord blood T regulatory
cell therapy
for type 1 diabetes» (2012)
In close collaboration with universities and physicians world - wide, our comprehensive investigational stem
cell treatments employ well - targeted combinations of allogeneic human umbilical cord stem
cells,
autologous bone marrow stem
cells, and
autologous adipose stem
cells for the diseases listed below.
Autologous vs. allogenic mesenchymal progenitor
cells for the reconstruction of critical sized segmental tibial bone defects in aged sheep.
For the first time, researchers demonstrate long term success of a
cell replacement therapy using
autologous induced pluripotent stem
cell derivatives
Although
autologous cell transplantation circumvents the need
for immunosuppressive treatment, it is not always available or most effective.
Embryonic
cell lines and
autologous embryonic stem
cells generated through therapeutic cloning have also been proposed as promising candidates
for future therapies.
For instance, during emergency care, allogeneic therapy is usually the only relevant option due to the time constraints of
autologous cell expansion.
Allogeneic Mesenchymal Stem
Cells Stimulate Cartilage Regeneration and Are Safe
for Single - Stage Cartilage Repair in Humans upon Mixture with Recycled
Autologous Chondrons.
As Dr. Maharaj explained, «One last option
for Gale was high dose chemotherapy followed by an
autologous bone marrow stem
cell transplant.
The US Food and Drug Administration (FDA) has granted Priority Review designation
for tisagenlecleucel (Kymriah), formerly known as CTL019,
for treatment of adult patients with relapsed or refractory diffuse large B -
cell lymphoma (DLBCL) who are ineligible
for, or have relapsed after,
autologous stem
cell transplant.
These results, published today (December 12) in Nature Biotechnology, have implications
for autologous transplantation — creating a replacement tissue from a patient's own
cells — something that older people are more likely to need, the authors noted.
Another example is AMDC —
autologous adult skeletal muscle primary
cells that are expanded in culture prior to injection and are tested
for the treatment of ischemic heart failure.
Possible solutions can be provided by use of MSCs, which are known
for their immunomodulatory properties, iPSCs, which are derived from the patient's own tissue, and of course
autologous cell sources.
Clinical - scale Rapid
Autologous BK - virus Specific T
Cell Line generation from Kidney Transplant Recipients with Active Viremia
for Adoptive Immunotherapy.
Unfortunately, the source
for patient - specific /
autologous eCS
cells comes from invasive heart biopsies which provide scant numbers of
cells.
Therapy With
Autologous Adipose - Derived Regenerative
Cells for the Care of Chronic Ulcer of Lower Limbs in Patients with Peripheral Arterial Disease (March 20, 2013) in Journal of Surgical Research.
For example,
autologous bone marrow stem
cells injected into the brain require FDA review.
For example, clinics may offer
autologous (from your own body) stem
cell treatments, which may not be subject to oversight if the
cells are minimally manipulated.
Thus,
for the specific example you gave of using
autologous bone marrow stem
cells injected into the brain, this scenario would indeed require full FDA approval as it does not meet the criteria of homologous use, as you said.
Manufacturing Models Permitting Roll - Out / Scale - Out of Clinically Led
Autologous Cell Therapies: Regulatory and Scientific Challenges
for Comparability.
High - Dose Chemotherapy Plus Transplant Not Recommended
for DLBCL: The results of an Italian study report that treatment of high - risk diffuse large B -
cell lymphoma (DLBCL) with abbreviated course of rituximab dose - dense chemotherapy plus high - dose cytarabine, mitoxantrone, and dexamethasone (R - MAD) plus carmustine, etoposide, cytarabine, and melphalan (BEAM) plus
autologous stem
cell transplantation compared with a full course of rituximab dose - dense chemotherapy did not improve overall survival.
CRP Levels Before Transplant Linked With Survival in Multiple Myeloma: According to a new study, patients with an elevation in C - reactive protein (CRP) prior to an
autologous stem
cell transplantation (ASCT)
for multiple myeloma experienced a worse overall survival (OS) rate.
Although regulatory precedents have been set
for various
autologous and allogeneic products in the United States, Asia, and the European Union, regulatory guidance continues to evolve
for a widening array of
cell products.
Autologous cell therapies require a fundamentally different manufacturing approach, and we did not identify any DSTs designed specifically
for such processes.
For example, we're one of a handful of hospitals in the country to offer total pancreatectomy with islet
cell autotransplantation (
autologous islet
cell transplantation), a procedure aimed at preventing diabetes or reducing its effects after removal of the pancreas due to pancreatitis.