[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

Managed Access Programs for CTL019, Tisagenlecleucel

The purpose of this registration is to list Managed Access Programs (MAPs) related to CTL019, Tisagenlecleucel

[Trial of device that is not approved or cleared by the U.S. FDA]

Expanded Access Program for Tiratricol in Patients With Monocarboxylate Transporter 8 Deficiency

The goal of this program is to provide expanded access (i.e., before marketing authorization) to tiratricol as treatment for patients with monocarboxylate transporter 8 deficiency (MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome \[AHDS\]), who in their Treating Physician's opinion, could benefit from tiratricol and meet the eligibility criteria.

Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer

The purpose of this Medical Access Program (also referred to as an Expanded Access Program in the USA) is to provide access to I-DXd for eligible patients with extensive-stage small cell lung cancer (ES-SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen), and for eligible patients who have no suitable treatment options and are not able to enter a clinical study.

[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)

This Expanded Access Program provides investigational access to leronlimab (PRO 140) for patients with advanced or metastatic triple-negative breast cancer (TNBC) who lack satisfactory treatment options and are unable to participate in a clinical trial.

[Trial of device that is not approved or cleared by the U.S. FDA]

"An Intermediate Size Patient Population Expanded Access Protocol to Evaluate the Safety and Efficacy of Allogeneic HB-adMSCs (Hope Biosciences - Adipose Derived Mesenchymal Stem Cells) for the Treatment of Multiple System Atrophy."

This expanded access protocol is part of IND 32226 to evaluate efficacy and safety of multiple intravenous administrations of allogeneic HB-adMSCs for the treatment of Multiple System Atrophy for up to 7 adult patients who pass pre-screening and a completed screening. The subjects will receive 12 intravenous infusions of HB-adMSCs and 6 intrathecal injections of HB-adMSCs over the course of 44 weeks (1 infusion each month and 1 injection every other month).

[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

Treatment of Dravet Syndrome With Fenfluramine (Expanded Access Protocol)

The purpose of this research study is to (1) provide access to fenfluramine for patients with intractable epilepsy associated with Dravet syndrome, and (2) evaluate the safety of fenfluramine.

[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

[Trial of device that is not approved or cleared by the U.S. FDA]

Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDS

Single patient expanded access program to provide galinpepimut-S for eligible patients with AML or MDS who have no other treatment option.