This study is a multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of ExoFlo for the treatment of moderate-to-severe ARDS (Acute Respiratory Distress Syndrome). The purpose of this study is to research and evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for Moderate-to-Severe ARDS. Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles is an investigational drug created from human bone marrow being studied for the treatment of moderate-to-severe ARDS. This is a research study that will involve monitoring oxygen and inflammation levels after taking the investigational product and assessing the safety of the investigational product. The experimental treatment is a biologic product called Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles Allograft Product ExoFlo, which is purified from the bone marrow of a healthy well-screened individual. Participants will receive either 15mL of the investigational product with 85 mL of normal saline or 100 mL of normal saline only (placebo). The expected duration of participation in the study is a maximum of 61 days, which includes 1-day screening prior to treatment and 60 days following the first treatment.
Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of donor derived mesenchymal stem cells to relieve chronic pain. After cell infusion into the vein, the participant will be followed for 6 months to evaluate their pain and other outcomes. There are a total of 5 clinic visits with a total study participation of up to 7 months.
This phase 3 study is recruiting patients who are at risk of graft-versus-host disease (GVHD) after a bone marrow transplant. This study will measure the safety and effectiveness of a prevention treatment combination called Tacrolimus/Methotrexate/Ruxolitinib compared to Standard of Care (SOC), Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil. Ruxolitinib (Rux) is an approved treatment for GVHD. This study is divided into two parts. The first part, called the run-in phase, will investigate the best dose of Ruxolitinib. The second part of the study will compare the SOC combination therapy with the investigational combination therapy (which will include Ruxolitinib). Participants will be randomly assigned to one of the two groups (like flipping a coin). The study will enroll up to 572 patients nationwide and 5 at MUSC. The participants can expect to be involved in the study for at least 24 months. The main risk is that medical treatments often cause side effects. The most common side effects expected from the investigational combination therapy are high cholesterol, increased liver enzymes, low platelet levels, and low red blood cell counts. There is no direct benefit for them in participating in this study.
This is a multicenter, randomized, open-label, Phase 3 study in participants with newly diagnosed multiple myeloma to evaluate the benefits of teclistamab in combination with lenalidomide and teclistamab alone versus lenalidomide alone as maintenance therapy after autologous stem cell transplant.
This is a clinical use of an FDA-approved Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE) called Miltenyi Biotec CliniMACS CD34. The intent is to treat patients with Myelodysplastic Syndrome (MDS) in a clinical setting, not to conduct research or gather data on safety or effectiveness. No data will be collected beyond what is required for standard clinical care. Device-related processing will occur at an NMDP Advanced Cell Therapy Lab Solutions facility, and the resulting cell product will be transported to MUSC Hollings Cancer Center for infusion. Eligible patients are in first complete remission and undergoing allogeneic stem cell transplant (SCT) from an HLA-identical matched related donor. Patients will be provided MUSC's standard treatment consent per institutional policies. The HUD will be stored, dispensed, and used at NMDP in accordance with standard operating procedures.
This is a Phase 3 randomized study to compare two new drug combinations of teclistamab with daratumumab and lenalidomide and talquetamab with daratumumab and lenalidomide versus standard of care in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy. The study is expected to continue for approximately 9 years.The Medical University plans to enroll 12 participants. The duration of participation will depend on the response of the study treatment. Subjects will receive treatment weekly or every 2 weeks. Medical history and physical examination, including lab tests like blood work and imaging, as well as questionnaires will be completed. Known risks include Cytokine Release Syndrome (CRS) as a complication that can happen due to the activation of immune cells.
This study aims to evaluate real-world effectiveness of pacritinib through a site-based retrospective chart review of medical records of adult patients with myelofibrosis treated with pacritinib in routine clinical settings with platelet count ≥50 x 10^9/L at the time of treatment initiation. Treatment effectiveness will be based on spleen size and symptom burden, hematological parameters, progression to leukemia, survival, pacritinib treatment patterns, patient demographic and clinical characteristics, and allogenic-hematopoietic stem cell transplant (allo-HSCT)-related outcomes. Data will be collected from medical charts of patients with pacritinib initiation between 01 June 2022 and 31 December 2025 with an end of study observation on 30 June 2026.