A Study of the Safety and Tolerability of ASP7317 in Adults Who Are Losing Their Clear, Sharp Central...
Age-Related Macular DegenerationThis study is for adults 50 years or older who are losing their clear, sharp central vision. Central vision is needed to be able to read and drive a car. They have been diagnosed with dry age-related macular degeneration (called dry AMD). The macula is the center part of the back of the eye that allows you to see fine detail. In an advanced stage of this disease, areas of the macula die (atrophy), resulting in vision loss. This is called geographic atrophy. This study is looking at a new treatment called ASP7317. It is for slowing or reversing atrophy in dry AMD. ASP7317 is a specially created type of cells derived from human stem cells. ASP7317 cells are injected into the macula of the eye while the person is under anesthesia (local or general). An immunosuppressive medicine (tacrolimus) is also taken around the time of injection of the cells to prevent the body from rejecting them. This study looks at how safe ASP7317 is at 3 different dose levels. Researchers want to learn if the different dose levels of ASP7317 work without causing unwanted medical problems. Each of the 3 doses will be given to 2 groups of people. The first group will be those who have severe vision loss. The second group will be those who have moderate vision loss. The doses are low, medium and high numbers of cells. Tacrolimus will be taken by mouth for 34 days, starting around the time of the injection of ASP7317. In addition, medicines to prevent infection will be taken by mouth for up to 4 weeks starting around the time ASP7317 cells are injected. Each week for the first 4 weeks after the ASP7317 cells have been injected, people taking part in the study will visit the clinic so the researchers can make assessments. Then they will visit again, at weeks 6, 8, 12, 16, 26, and 52 (last week of the study). A substudy will be available at some clinics. These clinics will use a special camera that will allow researchers to look at images of the macular atrophy over time.
Trial of Parkinson's And Zoledronic Acid
Parkinson DiseaseOsteoporosis7 moreThis home-based study is a randomized (1:1) placebo-controlled trial of a single infusion of zoledronic acid-5 mg (ZA) for the prevention of fractures in men and women aged 60 years and older with Parkinson's disease and parkinsonism with at least 2 years of follow-up. A total of 3500 participants will be enrolled and randomized in the United States. Participants, follow-up outcome assessors, and study investigators will be blinded to assigned study treatment. This trial is funded by the National Institute of Aging.
Umbilical Cord Plasma for Treating Endometrial Pathologies (Thin Endometrium / Asherman's Syndrome/...
Asherman SyndromeEndometrial AtrophyIn the last years, platelet-rich plasma (PRP) has emerged as a promising alternative to treat endometrial pathologies affecting the endometrial lining. Different studies have tried this therapeutic approach in human patient, but results are not conclusive at all. Also, in the last years, different studies have suggested the umbilical cord blood has a stronger reservoir of growth factors and other pro-regenerative molecules than the adult peripheral blood. That is the reason why the present study aims to evaluate if using platelet-rich plasma obtained from umbilical cord blood is able to increase endometrial thickness and prepare the endometrium for an embryo transference. However, due to the novelty of this approach, the investigators have considered to include a 'proof of concept' group (women with premature ovarian insufficiency) to obtain a deeper understanding of the clinical value of this blood derivative.
Study of the Safety and Efficacy of an Adeno-Associated Viral Vector Carrying the SMN Gene After...
Spinal Muscular Atrophy (SMA)The goal of this multicenter, open-label, non-comparative, cohort study is to investigate the safety, immunogenicity, and efficacy of ANB-004 in children with spinal muscular atrophy. The study will have a standard 3+3 dose-escalation design.
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy...
Age-Related Macular DegenerationThis is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.
Local DHEA and Estradiol on Dyspareunia in Postmenopausal Women
Vulvovaginal AtrophyGenitourinary Syndrome of MenopauseVulvovaginal atrophy (VVA) is a condition characterized by vaginal dryness, itching, burning, irritation and dyspareunia. The condition is mainly due to estrogen deficiency and is common during and after menopause. Furthermore, androgens may have an important function in these symptoms. The purpose of the study is to compare vaginal estrogen with vaginal dehydroepiandrosterone (DHEA, an androgen precursor) on dyspareunia (primary outcome), a symptom of VVA in postmenopausal women. Secondary outcomes are total symptom score of VVA (vaginal dryness, irritation/itching, maturation index, pH), clinical signs of VVA, sexual function, urogenital symptoms, vaginal histomorphology, sex hormone levels and short-term safety. The hypothesis of the study is that the treatments will have a similar effect on dyspareunia while DHEA, through local androgenic effects (eg growth of muscle tissue and nerve density in the vaginal wall), may be more effective in treating other related symptoms such as sexual dysfunction. 170 postmenopausal women will be randomly assigned to treatment with either vaginal estrogen (Vagifem) or vaginal DHEA (Intrarosa). The women are examined at the start of the study, after 4 weeks of daily application and after another 8 weeks of treatment with twice a week application of the vaginal treatment. The study is expected to provide increased knowledge about the effect of the treatments of VVA in postmenopausal women as well as whether vaginal DHEA has additional positive effects on sexual function compared to vaginal estrogen.
Clinical Study of Manpixiao in the Treatment of Chronic Atrophic Gastritis
Chronic Atrophic GastritisTo explore the efficacy and safety of "Manpixiao" in the treatment of Chronic Atrophic Gastritis.
Spinal Muscular Atrophy on Wheels, Using Power Mobility
Spinal Muscular AtrophyThe group of children diagnosed with Spinal Muscular Atrophy (SMA) has serious restrictions on participation. SMA is a neuromuscular disease that leads to neuromusculoskeletal disorders that limit functional activities, sometimes making it impossible to sit down autonomously and to walk. Scientific evidence has highlighted the importance of implementing physiotherapy interventions in pediatrics that facilitate the integration and participation of children with reduced mobility in their natural environment through the use of different assisted mobility devices that allow the child to acquire a degree of independence and motivation according to their potential and needs. For some time, with the aim of offering independent movement opportunities for children with severe motor impairment, adapted electric cars have been used, as they are simple to use and easy for the child and family to incorporate into daily tasks within natural environments. These low-cost motorized devices can generate a very positive impact on the participation of children diagnosed with SMA type I from an early age, after training the family and/or the child himself, guaranteeing the maximum possible safety, comfort, motivation and autonomy. Due to the above, there is a need to carry out the research project defined below, to generate opportunities for the inclusion of children diagnosed with SMA type I through the use of low-cost electric cars that encourage their participation, motivation and quality of life.
LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast...
Vaginal AtrophyVulva; Atrophy1 moreThis is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.
Stem Cell Ophthalmology Treatment Study II
Retinal DiseaseAge-Related Macular Degeneration17 moreThis study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.