El Cajon

Researchers are evaluating the safety and effectiveness of JointStem, a treatment made from a patient's own fat tissue stem cells, in adults with knee osteoarthritis. This phase 2b/3a, double-blind, placebo-controlled study involves about 140 participants randomly assigned to receive either JointStem or a placebo. The study lasts 48 weeks, with the goal to see if JointStem improves knee function and reduces pain compared to placebo. Participants undergo a 2-week screening period before being randomly assigned to one of two groups in a 1:1 ratio. At baseline, participants have fat tissue collected for stem cell preparation (lipoaspiration). At week 0, they receive an injection either of JointStem or a saline placebo with their own serum. Follow-up visits occur at weeks 4, 12, 24, 36, and 48 to monitor progress and safety. After the final visit, study data are reviewed and the blind is opened for analysis. During the study, participants will have their knee function and pain measured using standardized scores at the start and after 48 weeks. Researchers also conduct physical exams, laboratory tests, and X-rays to monitor health and disease status. Participants must stop most pain medications before and during the study except acetaminophen as needed. Safety is closely tracked throughout the 48-week period.

Researchers are evaluating the safety, tolerability, and effectiveness of IMVT-1402 in adults with moderate to severe systemic primary Sjogren's disease. This Phase 2b study compares IMVT-1402 to a placebo using a double-blind, randomized, placebo-controlled design. The main goal is to see how the treatment affects disease activity scores over 24 weeks, with participation lasting up to 105 weeks. Participants receive either IMVT-1402 or placebo through weekly subcutaneous injections. The study carefully monitors changes in disease activity, focusing on a clinical score called clinESSDAI. The trial includes a long observation period to track both the treatment's effects and safety over time. During the study, participants undergo evaluations at the start and at week 24 to measure changes in their disease activity. Researchers will also monitor safety and tolerability throughout the entire study period. Participants are assessed for antibody status, salivary flow, and systemic disease activity to understand the impact of the treatment fully.

Researchers are evaluating the effectiveness and safety of CARTISTEM4, a product made from human umbilical cord blood-derived mesenchymal stem cells combined with a cross-linked sodium hyaluronate hydrogel. This phase 3 trial compares CARTISTEM4 to a surgical procedure called debridement in adults with knee cartilage lesions and osteoarthritis. The study aims to show whether CARTISTEM4 can better reduce knee pain and improve knee function over two years, and also to explore if it can slow osteoarthritis progression using MRI assessments. Participants will receive either the CARTISTEM4 treatment, which includes a gel made from stem cells and sodium hyaluronate, combined with debridement, or debridement alone to remove unstable cartilage in the knee. CARTISTEM4 is prepared by mixing about 7.5 million stem cells with sodium hyaluronate to form a gel. The treatments will be administered at the start of the study, followed by monitoring over the next two years. Throughout the study, participants will have regular evaluations including pain assessments using the Visual Analog Scale and function evaluations using the WOMAC4 index from treatment start up to 24 months follow-up. Imaging, such as MRI, will be used to assess cartilage and osteoarthritis changes. Participants will also be monitored for safety and ability to follow rehabilitation requirements during the study period.

Arab Americans face unique challenges in managing type 2 diabetes due to limited culturally and linguistically appropriate educational resources and support. This research evaluates a diabetes self-management education program adapted specifically for Arab Americans, called Project Dulce Arabic. The goal is to improve diabetes knowledge, health beliefs, self-management behaviors, and blood sugar control, while also exploring the role of genetics in type 2 diabetes within this community. Project Dulce Arabic includes a 5-week peer-led group education program delivered in Arabic that covers diabetes basics, complications, diet, exercise, medication, self-monitoring, and genetics. After completing the curriculum, participants join Dulce Digital, a 3-month text messaging program providing ongoing support, medication reminders, and blood glucose monitoring prompts in Arabic. This approach aims to address cultural and language barriers and enhance diabetes management. Participants will be involved throughout the study by attending education sessions and receiving text messages. Researchers will assess changes in diabetes knowledge, health beliefs, self-efficacy, and understanding of genomics at 3 and 6 months. Blood sugar control will also be monitored. Participants’ genetic samples may be collected for sequencing to study the genetic basis of diabetes in Arab Americans. The study evaluates the program’s impact on improving diabetes care and awareness over a 6-month period.