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Found 21 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying a treatment for people with Congenital Myasthenic Syndrome, a condition that affects muscle function. This clinical trial is a Phase 1, single-arm, non-controlled study aiming to evaluate a new therapy using exosomes derived from mesenchymal stem cells. The study involves a prospective evaluation of patients before treatment and tracks outcomes after the treatment is given. Participants will receive an intranasal treatment called AlloEx exosomes, which contains exosomes from mesenchymal stem cells. This biological treatment is administered through the nose in a single-arm study without a comparison group. There are no details about dose escalation or multiple treatment phases, focusing on the delivery and assessment of this investigational therapy. During the study, patients will be monitored from enrollment up to six months after treatment. The main outcome measured is oxygen saturation levels over this period. Patients will be evaluated before and after treatment, with continuous tracking of their progress and safety. The total duration of participation includes the treatment and a six-month follow-up to observe the effects of the therapy.

Age: 18Years +All GendersPhase 1
3 locations
S

Actively Recruiting

This research aims to evaluate the safety and effectiveness of intranasal delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes for treating stroke. It is a phase 1 patient-funded trial focused on patients diagnosed with stroke, exploring a novel biological therapy to potentially improve recovery outcomes. Participants will receive intranasal instillations of the treatment called AlloEx, which contains approximately 800 billion exosomes in a total dose of 4 CC per day. The treatment is given on two consecutive days, with doses administered into both nasal cavities. For patients with more severe stroke, an additional treatment using autologous effector cells created from the patient's own activated lymphocytes obtained by apheresis may be used. Participants will be assessed for safety and effectiveness starting within one month before treatment and followed up at 1, 6, 12, 24, 36, and 48 months afterward. The main outcome measured is safety, specifically monitoring adverse events over a four-year follow-up period. Evaluations include clinical examinations and laboratory tests to ensure participant well-being throughout the study.

All GendersPhase 1
2 locations
S

Actively Recruiting

This trial investigates the safety and effectiveness of intranasal administration of cultured allogeneic adult umbilical cord derived mesenchymal stem cell exosomes (called AlloEx) for treating Parkinson's Disease. It is a patient-funded Phase 1 study aiming to evaluate how well this new treatment works and its safety over an extended period. Participants will receive two doses of AlloEx, each dose consisting of 4 CCs containing about 800 billion exosomes, administered through both nasal cavities on two consecutive days. The trial monitors participants closely before treatment and at several points afterward, including 1 month, 6 months, 12 months, 24 months, 36 months, and 48 months. Throughout the study, patients will undergo safety and efficacy evaluations to assess any adverse events and treatment effects. The main outcome measured is safety, specifically tracking adverse events during a four-year follow-up. Participants will have laboratory tests and clinical assessments as part of these ongoing evaluations to ensure their well-being and to monitor the treatment's impact over time.

All GendersPhase 1
1 location
S

Actively Recruiting

This research aims to evaluate 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 and seeks to understand how this stem cell treatment impacts their condition over an extended period. Participants will receive a single intravenous infusion of 100 million UC-MSCs. The study involves one treatment phase where this stem cell solution, known as AlloRx, is administered. Following the infusion, patients will be monitored closely to assess both safety and treatment benefits. Before treatment, patients will be evaluated within one month, then followed up at 1, 6, 12, 24, 36, and 48 months after the infusion. Researchers will monitor for any adverse effects and overall safety throughout this four-year period. The long-term follow-up helps ensure a thorough understanding of the treatment's impact and safety profile over time.

All GendersPhase 1
3 locations
S

Actively Recruiting

Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells as a treatment for Autism. This Phase 1 trial focuses on understanding how this stem cell therapy may impact patients with Autism by monitoring safety and efficacy outcomes. Participants will receive a single intravenous infusion containing a total dose of 100 million cultured allogeneic adult umbilical cord derived mesenchymal stem cells called AlloRx. The treatment involves one administration followed by a long-term follow-up period. Participants will be evaluated before treatment and then at 1, 6, 12, 24, 36, and 48 months after receiving the infusion. These evaluations will include monitoring for adverse events and assessing the treatment's safety and efficacy over four years.

All GendersPhase 1
3 locations
S

Actively Recruiting

Researchers are evaluating the safety and effectiveness of intravenous infusion of cultured allogeneic adult umbilical cord-derived mesenchymal stem cells (UC-MSCs) for treating Chronic Kidney Disease (CKD). This patient-funded Phase 1 trial focuses on studying these stem cells as a possible treatment option for CKD, building on previous studies showing promising safety and efficacy. For patients with more severe CKD, an additional treatment using autologous effector cells made from their own activated lymphocytes will be considered. Participants will receive a single intravenous infusion of UC-MSCs at a dose of 100 million cells. Those with more severe disease may also receive the autologous effector cell treatment created through apheresis from their own cells. The study involves evaluations before treatment and multiple follow-up visits at 1, 6, 12, 24, 36, and 48 months after treatment to assess safety and effectiveness. During the study, participants will undergo various clinical assessments to monitor safety, including checking for adverse events over a four-year period. Researchers will evaluate laboratory tests and other clinical measures at scheduled visits. The long-term follow-up will help determine how well the treatment works and whether it is safe over time, with careful monitoring throughout the entire 48-month period.

All GendersPhase 1
1 location
S

Actively Recruiting

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 Cerebral Palsy (CP). This patient-funded phase 1 trial is based on previous studies suggesting stem cell treatments may be safe and helpful for CP. The goal is to better understand how these stem cells work in people with this condition and monitor any safety concerns over time. Participants diagnosed with CP will receive a single intravenous infusion containing a total dose of 100 million UC-MSCs, called AlloRx. The treatment involves one administration of these cultured stem cells delivered through the bloodstream. There are no comparator groups mentioned, and all participants undergo the same intervention. Participants will be assessed before treatment and then followed closely at 1, 6, 12, 24, 36, and 48 months after the infusion. Evaluations will focus on safety by monitoring any adverse events and also look for signs of treatment effectiveness. This long-term follow-up over four years helps researchers understand both immediate and lasting effects of the stem cell infusion for CP.

All GendersPhase 1
2 locations
S

Actively Recruiting

Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells in treating inflammatory bowel disease (IBD), which includes Crohn's disease and Ulcerative Colitis. This Phase 1 trial aims to study whether this stem cell treatment can be safely administered to patients with IBD. For patients with more severe disease requiring chemotherapy drugs like methotrexate, an additional treatment using an autologous T cell vaccine made from the patient's own cells will be provided. Participants will receive a single intravenous infusion containing 100 million cultured stem cells derived from adult umbilical cords. The treatment group involves this one-time administration of the stem cells. Patients with more severe disease may also be treated with the autologous T cell vaccine created from their own T cells collected by apheresis. Before treatment, patients will be assessed within one month, and then followed closely at 1, 6, 12, 24, 36, and 48 months after treatment. During these visits, researchers will monitor safety by tracking any adverse effects and evaluate the treatment's effectiveness. The total follow-up period for safety is four years, allowing long-term observation of participants' health and response to the therapy.

All GendersPhase 1
2 locations
S

Actively Recruiting

Researchers are evaluating the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for treating Idiopathic Pulmonary Fibrosis (IPF). This Phase 1 trial aims to study how this stem cell treatment affects patients with IPF, including those with more severe disease who may require additional therapies such as an autologous T Cell vaccine made from their own cells. Participants will receive a single intravenous infusion containing 100 million cultured stem cells. Those with more advanced disease who need chemotherapy drugs like methotrexate may also be treated with a vaccine created from their own T cells collected through apheresis. Treatments are delivered in this one-time infusion followed by close monitoring. Patients will be assessed before treatment and then monitored at 1, 6, 12, 24, 36, and 48 months afterward to evaluate safety and treatment effects. Researchers will track adverse events and other health measures over four years to understand the long-term safety of the stem cell infusion for IPF.

All GendersPhase 1
1 location
S

Actively Recruiting

This research aims to evaluate the safety and effectiveness of a special stem cell treatment for Lupus, a chronic autoimmune disease. The study focuses on using cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs), examining their impact and safety over a long period. It is a Phase 1 trial motivated by previous studies showing that stem cell therapy can be safe and helpful for Lupus patients. Participants will receive a single intravenous infusion containing 100 million UC-MSCs. For those with more severe forms of the disease, an additional treatment involving an autologous T-Cell vaccine made from the patient's own cells will be used. The trial includes multiple follow-up visits scheduled at 1, 6, 12, 24, 36, and 48 months after treatment to monitor both safety and how well the treatment works. During the study, patients will undergo evaluations before treatment and at each follow-up visit, including safety monitoring through adverse event tracking. Researchers will assess the treatment's effects and watch for any side effects over a four-year period. This extended monitoring helps ensure a thorough understanding of the treatment's safety profile and potential benefits for Lupus patients.

All GendersPhase 1
2 locations

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