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Results from a phase 1/2 clinicaltrial of a novel stem cell treatment for cornea injuries found 14 patients treated and tracked for 18 months had a more than 90% success rate at restoring the cornea's surface and improvements in vision.
Researchers conducted the first clinicaltrial of an AI-powered therapy chatbot and found that, on average, people with diagnosed mental disorders experienced clinically significant improvements in their symptoms over eight weeks, according to new results.
As clinicaltrials become increasingly complex, particularly in decentralized trials and rare disease studies, sponsors experience increased challenges in site selection, forecasting and resourcing, and patient recruitment and enrollment. Discover how AI is used to optimize key aspects of clinicaltrial management.
MONDAY, May 6, 2024 -- An injectable gene therapy caused measurable improvements in vision among a small group of people with inherited blindness, an early-stage clinicaltrial says.Researchers recruited 14 people with Leber Congenital Amaurosis.
Adults with hemophilia B saw their number of bleeding episodes drop by an average of 71 percent after a single infusion of gene therapy, according to the new results of an international Phase III clinicaltrial.
A new clinicaltrial of five children with inherited deafness found administering gene therapy in both ears led to restored hearing and speech, and additional gains including sound source localization, ability to hear in noisy environments, and for two children, abillity to appreciate music.
25, 2024 -- A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinicaltrial data shows. THURSDAY, Sept. People with hemophilia B saw their bleeding episodes.
TUESDAY, June 25, 2024 -- An experimental stem cell therapy can essentially cure type 1 diabetes by restoring insulin production in some patients, early clinicaltrial results show.Seven out of 12 patients no longer needed daily insulin shots after.
The study provides both mechanistic and preclinical evidence supporting the rapid initiation of clinicaltrials for patients with acute myeloid leukemia (AML) to test an existing medicine that inhibits the complex, called eganelisib, both alone and in combination with the most used AML chemotherapy, cytarabine.
MONDAY, June 12, 2023 -- A clinicaltrial that’s attempting to discover a cure for sickle cell disease has found a new gene therapy to be safe and successful in four patients. Two of the patients were treated at Cleveland Clinic Children’s in.
25, 2024 -- A new gene therapy approved earlier this year can serve as a sustainable single-dose treatment for people with hemophilia B, newly published clinicaltrial data shows.People with hemophilia B saw their bleeding episodes. THURSDAY, Sept.
A group of independent experts wasn't convinced by clinicaltrial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.
TUESDAY, June 6, 2023 -- Radiation therapy might not be necessary in treating some forms of rectal cancer and lymphoma, sparing patients from the toxic treatment, a pair of new clinicaltrials shows. One trial found that rectal cancer patients.
A novel gene therapy for hearing loss was administered to six children in China in a clinicaltrial. Each child had an inherited deafness caused by mutations in the OTOF gene, called DFNB9.
15, 2023 -- Patients with advanced heart failure can benefit from stem cell therapy, a large, new clinicaltrial has found.Injections of stem cells programmed to heal damaged heart tissue wound up improving overall quality of life for. FRIDAY, Dec.
Expert advisers to the agency voted 17-1 that Brainstorm's clinicaltrial data did not show the company's stem cell treatment was effective for treating ALS.
However, recent breakthroughs in AI, such as predictive modelling, clinicaltrial optimisation, and personalised medicine, have demonstrated its potential. At the heart of Unlearns approach is the use of AI to improve clinicaltrials, especially in phases two and three.
Expert advisers to the agency voted 17-1 that Brainstorm's clinicaltrial data did not show the company's stem cell treatment was effective for treating ALS.
A large-scale clinicaltrial of treatment strategies for Crohn's disease has shown that offering early advanced therapy to all patients straight after diagnosis can drastically improve outcomes, including by reducing the number of people requiring urgent abdominal surgery for treatment of their disease by ten-fold.
21, 2023 -- A new treatment appears to reduce food allergies in children and teens, according to interim clinicaltrial results.A THURSDAY, Dec. lab-made monoclonal antibody called omalizumab (Xolair) significantly increased the amounts of common.
Before a potential new therapy can be administered to patients, it must go through several clinicaltrial phases designed to test the drug or device for safety and effectiveness. For many new treatments, it will take approximately ten years for the therapy to progress from initial discovery to being approved.
In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.
22, 2024 -- At-home brain stimulation therapy can safely and effectively treat severe to moderate depression, a new clinicaltrial shows.Rates of treatment response and depression remission were three times higher in people receiving. TUESDAY, Oct.
THURSDAY, June 27, 2024 -- Acupuncture can help breast cancer patients deal with the hot flashes that often accompany hormone therapy, a new clinicaltrial says.Nearly 2 in 3 women who got acupuncture during hormone therapy reported fewer and less.
Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to new research.
Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinicaltrials. Clinicaltrials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.
Before any new treatment or therapy is able to be used by the patient population, it must go through the process of a clinicaltrial — this is the case for any new prescription drug, but also true for over-the-counter medications, medical devices, and more.
14, 2023 -- A new study is adding to evidence that the party drug "ecstasy" can boost the benefits of talk therapy for people suffering from post-traumatic stress disorder (PTSD). In a clinicaltrial, researchers found that three. THURSDAY, Sept.
By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations. Operationalizing these trials requires proactive and flawless management at every stage.
An efficacy endpoint in oncology is a characteristic or variable that measures how beneficial a treatment is to a patient’s feeling, function, and survival in a clinicaltrial. They are essential for assessing whether new cancer therapies are safe and efficacious [1].
Novel stem cell therapy called a CALEC transplant was performed safely in four patients with serious chemical burns tracked in a phase I clinicaltrial for 12 months.
MONDAY, June 5, 2023 -- An experimental targeted therapy can dramatically slow the progress of common slow-growing brain cancers, a new clinicaltrial finds. The oral drug vorasidenib nearly tripled progression-free survival in patients with grade.
Before becoming available to patients, every medication, therapy, and intervention must undergo a rigorous approval process: the clinicaltrial. Clinicaltrials are divided into phases that are aimed at testing the safety and efficacy of every potential new treatment before it is able to enter the market.
In rheumatoid arthritis (RA) clinicaltrials, accurately measuring the effectiveness of treatments is critical for determining their value in managing this chronic and debilitating condition.
As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. Accelerate your drug development and clinicaltrial goals and benefit from our 360° CDMO and CRO solutions and expertise.
Applying CAR T-cell therapy in new clinical settings presents unique challenges. Worldwide ClinicalTrials is at the forefront, partnering with drug development teams to map this new path forward.
Clinicaltrials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinicaltrials requires efficient communication and coordination among various stakeholders.
FRIDAY, June 16, 2023 -- Testosterone replacement therapy is safe for most men with heart problems who also have been diagnosed with a low testosterone disorder, a new clinicaltrial has concluded. The trial found that testosterone replacement did.
Discover how incorporating genetic counseling and genetic services can unlock larger, more diverse and better qualified patient populations for your clinicaltrials. png Listing Introduction Overcome clinicaltrial recruitment barriers. Click here to login. Listing Image GenomeMedical_ListingLogo_250x190.png
Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinicaltrial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
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