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This research focuses on patients diagnosed with Congenital Myasthenic Syndrome, aiming to evaluate the effects of a treatment using mesenchymal stem cell exosome solution. The study is a Phase 1, single-arm, non-controlled trial where patients are assessed before treatment and monitored afterward to track outcomes such as oxygen saturation over a six-month period. Participants receive an experimental intranasal treatment called AlloEx exosomes, which are derived from mesenchymal stem cells. The study involves prospective evaluation of patients, treatment administration, and follow-up assessments but does not include a control or placebo group. During the trial, participants will undergo regular monitoring from enrollment up to six months after treatment to evaluate oxygen saturation levels. The study requires patients to visit the treatment site and provide informed consent. The trial is sponsored by The Foundation for Orthopaedics and Regenerative Medicine and is designed to carefully track patient outcomes following the investigational treatment.

Researchers are evaluating the safety and effectiveness of intranasal instillation of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes as a treatment for stroke. This Phase 1 trial explores a novel approach aiming to improve outcomes for stroke patients. The study is sponsored by The Foundation for Orthopaedics and Regenerative Medicine and focuses on monitoring safety over an extended period. Participants will receive two doses of AlloEx, a biological treatment containing approximately 800 billion exosomes, administered as 4 CCs intranasally into both nasal cavities on two consecutive days. For patients with more severe stroke, an additional treatment involving autologous effector cells derived from the patients own blood cells may be used. This procedure involves collecting cells through apheresis and activating lymphocytes. Participants will be evaluated before treatment and at multiple time points after treatment, including 1, 6, 12, 24, 36, and 48 months. Safety will be assessed by monitoring adverse events throughout a four-year follow-up. Researchers will also evaluate the treatments effectiveness during these visits. The total study duration allows for long-term observation of outcomes and potential side effects.

Researchers are evaluating the safety and effectiveness of using cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes delivered through the nose to treat Parkinsons Disease. This patient-funded Phase 1 trial focuses on understanding how these biological exosomes may impact patients with this condition over a four-year period. Participants will receive two doses of the investigational treatment called AlloEx, each consisting of 4 CCs containing approximately 800 billion exosomes, administered intranasally on consecutive days. This treatment group represents the experimental intervention being studied. Participants will be assessed before treatment and then followed up at 1, 6, 12, 24, 36, and 48 months after treatment. Safety will be monitored through adverse event tracking, and efficacy evaluations will also be conducted throughout the study. This long-term follow-up aims to provide comprehensive information about the treatments impact over four years.

Researchers are evaluating the safety and effectiveness of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs for treating Aging Frailty. This patient-funded phase 1 trial focuses on patients diagnosed with Frailty, aiming to assess how well this stem cell treatment works and its safety profile. Participants will receive a single intravenous infusion of 100 million UC-MSC cells. The treatment involves just one dose administered intravenously, with no placebo or comparison group mentioned. The study includes follow-up visits at 1, 6, 12, 24, 36, and 48 months after treatment to monitor patient outcomes. During the study, participants will be evaluated before treatment and at multiple time points afterward to check for safety and treatment effects. Researchers will watch for any adverse events over a four-year period. Assessments include clinical evaluations and laboratory tests to track safety and efficacy. Participants can expect regular monitoring visits as part of this long-term study.

Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for treating Autism. This phase 1 trial focuses on examining whether this stem cell treatment can be safely administered and how well it works in autism patients. Participants will receive a single intravenous infusion containing 100 million mesenchymal stem cells. The study involves only one treatment group receiving this infusion. There are no placebo or control groups, and the study follows patients over an extended period to monitor long-term effects. Participants will be evaluated before treatment and then followed up at 1, 6, 12, 24, 36, and 48 months after the infusion. These evaluations will include safety monitoring for any adverse events and assessments of treatment efficacy using the Autism Treatment Evaluation Checklist ATEC. This comprehensive follow-up ensures careful tracking of both safety and potential benefits over four years.

Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs for treating Chronic Kidney Disease CKD. This Phase 1 trial is patient-funded and aims to offer insights into the potential benefits and risks associated with this innovative stem cell treatment. For patients with more severe CKD, a different treatment using autologous Effector cells made from their own activated lymphocytes obtained by apheresis will be used. Participants will receive a single intravenous infusion of 100 million UC-MSCs. The study includes thorough monitoring periods before treatment and at multiple time points after treatment 1, 6, 12, 24, 36, and 48 months. This long follow-up helps researchers observe safety and efficacy over time. The alternate treatment for more severe cases involves cells created from the patients own blood. During the study, participants will undergo evaluations including laboratory tests to monitor safety and kidney function. Key measures include tracking adverse events and changes in creatinine levels and estimated glomerular filtration rate eGFR over four years. This comprehensive monitoring aims to provide detailed information on how the stem cell infusion affects participants, ensuring safety and assessing treatment outcomes throughout the study duration.

This research aims to evaluate the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells in treating Cerebral Palsy. The study is patient-funded and focuses on monitoring both safety and efficacy outcomes over a long period. Participants will receive a single intravenous infusion of 100 million umbilical cord derived mesenchymal stem cells. This is a Phase 1 interventional trial where the treatment group receives this experimental biological therapy. There are no placebo or comparator groups mentioned. Participants will be assessed before treatment and then at 1, 6, 12, 24, 36, and 48 months after infusion to monitor safety through adverse event tracking and efficacy through the Gross Motor Function Measure GMFM. The study includes a four-year follow-up period to evaluate long-term outcomes and safety. Total involvement spans multiple years with regular evaluations.

This trial investigates the safety and effectiveness of a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for patients with inflammatory bowel disease IBD, including Crohns disease and Ulcerative Colitis. It is a Phase 1 interventional study sponsored by The Foundation for Orthopaedics and Regenerative Medicine. The study also includes patients with more severe disease who may receive an autologous T Cell vaccine made from their own T cells. Participants will receive a single infusion containing 100 million stem cells. Patients with severe IBD requiring chemotherapy drugs like methotrexate may be treated with an autologous T Cell vaccine created from their own cells collected by apheresis. The study does not involve a placebo or masking. Participants will be evaluated before treatment and then at 1, 6, 12, 24, 36, and 48 months after treatment to monitor safety and effectiveness. Safety will be assessed by tracking adverse events over four years. Effectiveness will be evaluated using the Short Inflammatory Bowel Disease Questionnaire SIBDQ during the same follow-up period. The total participation lasts up to four years with regular assessments.

This research aims to evaluate the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells to treat Idiopathic Pulmonary Fibrosis IPF. The study is a Phase 1 trial focusing on patients diagnosed with IPF, investigating the potential benefits and risks of this stem cell treatment. For patients with more severe disease requiring chemotherapy drugs like methotrexate, an additional treatment using an autologous T Cell vaccine made from the patients own T cells will be used. Participants will receive a single intravenous infusion containing a total dose of 100 million cultured stem cells. The trial includes monitoring patients over a long period, with evaluations occurring one month before treatment and then at 1, 6, 12, 24, 36, and 48 months after treatment. Those needing chemotherapy will receive the T Cell vaccine created through apheresis of their own T cells. Throughout the study, patients will undergo safety assessments to monitor adverse events and efficacy evaluations including lung function tests like forced vital capacity and oxygen saturation tests. This follow-up will last for four years post infusion to carefully observe treatment effects and patient health. Participants will be closely monitored through scheduled visits to track their progress and any potential side effects.

This trial investigates the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs for treating Lupus. The study is patient-funded and focuses on evaluating this biological treatment in individuals diagnosed with Lupus. For those with more severe disease, an additional autologous T-Cell vaccine made from the patients own cells will be used. Participants will receive a single intravenous infusion containing a total dose of 100 million UC-MSCs. The treatment group is referred to as AlloRx. Patients with severe cases may also receive the T-Cell vaccine created through apheresis. This is a phase 1 interventional study without blinding or placebo control. Participants will be evaluated before treatment and then followed up at 1, 6, 12, 24, 36, and 48 months after infusion to monitor safety and efficacy. Researchers will specifically track safety by recording any adverse events over a four-year follow-up period. The total study duration for each participant spans up to four years from the initial treatment.