There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The drug for this submission is Hope Biosciences' allogeneic, first blood relative, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of a single patient with Pancreatic Cancer (PC). PC is an extremely infiltrative neoplasm that usually presents with vascular and perineural invasion in surgically resected tumors. Metastases to lymph nodes, liver and distant sites are all very common. Its incidence has markedly increased over the past several decades and ranks as the fourth leading cause of cancer death in the United States. Despite the high mortality rate associated with pancreatic cancer, its etiology is poorly understood. PC patients experience physiological symptoms such as anemia, ascites, severe fatigue, pain, cachexia, weakness, insomnia, confusion, and memory loss. The aggressive nature of PC leads to rapid deterioration of patients' quality of life and diminished ability to participate in treatment.
This Individual Patient Expanded Access IND has been created as requested by an 58-year-old man who suffers from Polyneuropathy due to Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin abnormalities (POEMS) Syndrome. The patient will receive 8 infusions of 200 million cells every four weeks during a 28-week period to relieve the symptoms of Polyneuropathy arising due to POEMS.
HBSCI02: This protocol is part of an FDA Individual Patient Non-emergency Expanded Access Request submitted on behalf of a 38-year-old father and husband who on August 4, 2017 at about 4:30pm, slipped off a boat head-first while in the Florida Keys for a family wedding, and was immediately unable to move his legs. He discharged to Texas via air ambulance for physical rehabilitation on August 23, 2017 with a diagnosis of ASIA B (American Spinal Injury Association) C-5 SCI (spinal cord injury). HBSCI04: This Individual Patient Expanded Access IND has been created per the request of a 75-year-old man who has been diagnosed with Spinal Cord Injury. The patient requested this Expanded Access IND with the purpose of possible restoration of nerve transmission and restoring sensation in his upper and lower body using intravenous autologous adipose derived mesenchymal stem cells. HBSCI05: This Individual Patient Expanded Access IND has been created per the request of a 26-year-old man who has been diagnosed with Spinal Cord Injury. The patient is a 26-year-old male who suffered an unstable C-6 compressive fracture, crushing the vertebral body and retropulsion of a large bone fragment into the vertebral canal, stenosing 75% of spinal canal in a diving accident on 12/4/2021 in Belize City, Belize. The injury classification is C-6 Asia A injury. The injury left him with flaccid paralysis below the level of C-7 dermatome.
This is a multicenter expanded access study of zanubrutinib monotherapy for participants with B-cell malignancies who are ineligible to enroll into any available zanubrutinib clinical trials
This is an Individual Patient Expanded Access Protocol of Autologous HB-adMSCs for the Treatment of Cerebral Palsy (CP) with the primary goal of treating 1 individual with CP who has exhausted all treatment options, his condition has not improved, his quality of life is severely affected by the condition and he has previously banked his mesenchymal stem cells. There are no FDA approved, fully restorative treatments for CP. The subject will receive 8 autologous HB-adMSC infusions of 50 million (50 x 10^6 cells) total cells. A protocol amendment to administer additional HB-adMSC infusions may be submitted for IRB/FDA for approval depending on the patient's response, AE/SAEs, and cell expansion characteristics.
This is a Single Patient Investigational New Drug (IND) to golimumab subcutaneous (SC) for the treatment of recently diagnosed Stage 3 type-1 diabetes mellitus (T1D) in children and young adults. The main purpose of a single patient IND is to provide treatment to participants with serious/life-threatening diseases or conditions prior to marketing authorization.
The intent of this open-label, multicenter expanded access program (EAP) is to provide early access to voxelotor prior to market authorization
This is a compassionate use protocol of BYL719 (alpelisib) treatment for a single patient with locally advanced lymphangioma positive PI3K alpha H1047R mutation.
This study is expanded access to an Investigational New Drug (IND) for an individual patient with spinal cord injury (SCI) at cervical spine 5-6 (C 5-6) designed to provide access to autologous adipose-derived mesenchymal stem cells (HB-adMSCs)
This protocol for compassionate use combines 2 different ways of fighting disease: antibodies and T cells. Both antibodies and T cells have been used to treat patients with cancers, and both have shown promise, but neither alone has been sufficient to cure most patients. This protocol combines both T cells and antibodies to create a more effective treatment. The investigational treatment is called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration. Prior studies have shown that a new gene can be put into T cells and will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes a piece of an antibody called anti-CD30. This antibody sticks to leukemia cells because they have a substance on the outside of the cells called CD30. For this protocol, the anti-CD30 antibody has been changed so that instead of floating free in the blood part of it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. The primary purpose of this protocol is to treat a single patient with a second dose of ATLCAR.CD30 T cells.