Westport

Researchers are evaluating the effectiveness and safety of IPN10200, a treatment for moderate to severe glabellar lines, which are wrinkle-like lines between the eyebrows. The study focuses on adult participants and includes both a double-blind phase comparing a single dose of IPN10200 to placebo, and an open-label phase assessing repeat doses over time. The study aims to understand how well IPN10200 works and how safe it is for improving these facial lines. Participants may receive IPN10200 or placebo injections into specific muscles in the glabellar region during the double-blind phase. In the open-label phase, new participants and those rolling over from the double-blind phase may receive IPN10200 for up to four treatment cycles. The study includes a screening period of up to 20 days, a treatment period with multiple visits in the first month followed by monthly visits, and a 24-week follow-up after the last injection to monitor health. Throughout the study, participants will have health assessments including blood tests, physical exams, clinical evaluations, and ECGs. They will also complete questionnaires and keep diaries. Researchers will measure treatment response at specific weeks using scales that evaluate wrinkle severity and participant satisfaction. Safety and long-term effects including antibody development and adverse events will be closely monitored. Each participant may be involved for up to 107 weeks and can withdraw at any time.

This research aims to evaluate the safety and effectiveness of ELAPR002f injectable gel in adults with moderate to severe atrophic acne scars. These scars are flat or indented marks that remain after acne heals and can affect quality of life through reduced self-esteem and embarrassment. The study is a controlled, randomized trial including about 395 adults with scarring on both cheeks, conducted at multiple sites in the United States. Participants are divided into two cohorts. Cohort 1 receives ELAPR002f injectable gel openly, while Cohort 2 participants are randomly assigned to receive either ELAPR002f gel or a saline control via intradermal injections. Treatments are given on Days 1, 31, and 61. After the three treatment sessions over two months, participants are followed for up to 12 months to observe outcomes and any side effects. During the study, participants will have regular visits at a clinic or hospital for medical assessments, blood tests, and questionnaires to monitor their progress and any side effects. Researchers will measure the percentage of participants who achieve at least a 20 reduction in acne scar area and various safety parameters, including injection site responses and changes in vital signs and laboratory values. The total study duration for each participant can be up to 420 days.

Researchers are gathering real-world data on the use of the commercially approved Intracept Intraosseous Nerve Ablation System to treat patients diagnosed with vertebrogenic pain, including chronic low-back pain. The study aims to observe how patients fare following this minimally invasive procedure in a naturalistic setting without altering standard care. Participants in this observational study will receive treatment with the Intracept device as per usual medical practice and local guidelines. The study does not involve assigning treatments but monitors outcomes after patients undergo the approved nerve ablation procedure for vertebrogenic pain. During the study, participants will be followed for up to 60 months after their procedure. Researchers will assess changes in disability using the Oswestry Disability Index at baseline and throughout the follow-up period. The study focuses on collecting data on patient outcomes over time to better understand the effects of this treatment in everyday clinical use.

This research aims to evaluate the use of autologous bone marrow derived stem cells BMSC delivered intravenously and intranasally to improve neurologic function in patients with various neurologic conditions. The study focuses on patients with documented functional damage to the central or peripheral nervous system that is unlikely to improve with current standard care. The investigators seek to add to existing knowledge by studying the effects of BMSC in conditions such as stroke, traumatic brain injury, Parkinsons disease, Alzheimers disease, and other neurodegenerative disorders. The treatment involves collecting the participants own bone marrow to isolate stem cells, which are then given through an intravenous infusion and applied topically to the lower third of the nasal passages on both sides. This intranasal approach targets the trigeminal nerve pathways that may help the stem cells enter the brain and central nervous system. Participants receive this combined intravenous and intranasal BMSC treatment during the study period. Participants will undergo neurologic function assessments at baseline and at 1, 3, 6, and 12 months after treatment to measure changes. They will be monitored through neurologic exams and evaluations to track potential improvements and safety. Medical stability and clearance by a primary care physician are required before treatment, and follow-up visits with neurologists are part of the study to observe outcomes over one year.

Researchers are studying the safety and effectiveness of ELLANSAE-S, a dermal filler, for treating nasolabial folds NLFs, which are the lines that appear around the nose and mouth. This is a prospective, randomized, multi-center, split-face, double-blind clinical trial comparing ELLANSAE-S to another dermal filler called RadiesseAE. The study will enroll 126 men and women aged 22 and older with moderate to severe NLFs. The trial aims to evaluate wrinkle improvement using the Wrinkle Severity Rating Scale WSRS and other aesthetic measures over time. Participants will receive ELLANSAE-S treatment on one side of the face and RadiesseAE on the other side. Initial treatment will be followed by an optional touch-up at 4 weeks, and some may receive retreatment at 12 or 18 months if the folds return to baseline or worsen by at least one point on the WSRS. Retreatment and touch-ups will be with ELLANSAE-S only. Safety visits and telephone follow-ups are scheduled at various intervals including 72 hours, 2 weeks, 4 weeks, and multiple months up to 24 months. The study will last about 30 months with all subjects followed for at least 24 months after initial treatment. Throughout the study, participants will undergo assessments including wrinkle severity scoring by masked reviewers, global aesthetic improvement ratings, pain evaluations, and questionnaires on satisfaction and appraisal of nasolabial folds. Safety is monitored closely with scheduled visits after each injection and touch-up. The primary effectiveness endpoint is the change in WSRS score at 6 months, with multiple secondary measures assessed up to 24 months. The study includes a diverse population with at least 20 having darker skin types Fitzpatrick IV-VI.

Researchers are evaluating the use of autologous bone marrow derived stem cells BMSC to treat vision loss caused by retinal or optic nerve damage that is generally considered irreversible. The study focuses on conditions such as macular degeneration, hereditary retinal dystrophies including retinitis pigmentosa and Stargardt disease, ischemic retinopathies, optic nerve damage from glaucoma, ischemic optic neuropathy, and optic atrophy. The goal is to assess whether these stem cells can improve vision in affected eyes. Participants will receive a combination of injections of their own bone marrow derived stem cells through several methods, including retrobulbar, subtenon, intravenous, intravitreal, intraocular, or subretinal injections. The treatment is administered using standard medical and surgical techniques. The study has one treatment group receiving these injections in one or both eyes. After treatment, participants will be followed for 12 months, during which they will have regular comprehensive eye exams with imaging and diagnostic tests. Throughout the study, participants will undergo assessments such as visual acuity tests, visual field measurements, and Optical Coherence Tomography OCT scans to monitor changes from before the procedure to 12 months after. Researchers will track vision improvements and any changes in eye structure or function. Safety and health will be closely monitored, and participants must attend follow-up eye exams as scheduled. The total participation time is about one year post-treatment.