Sponsor Overview
Explore verified public information about Medregen LLC's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 2 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 1 supporting sources.
“In these circumstances, Medregen will consider providing a requesting physician with access to the investigational drug MRG-001, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met.”
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria
- The patient has a serious or potentially life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option; 2. A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available; 3. Making the investigational drug available will not negatively impact or significantly delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access; and 4. Adequate supply of the investigational drug is available. Available Therapies via Single-Patient EA Medregen is able to provide the investigational drug MRG-001 via single-patient EA. MRG-001 is a novel combination drug that is able to mobilize endogenous bone marrow-derived stem cells and immunomodulatory cells to the site of injury and induce repair/regeneration and immunomodulation. MRG-001 is currently under investigation for the following indications and EA use of MRG-001 can be considered for all indications and potentially other indications: -Acute Respiratory Distress Syndrome -Amyotrophic Lateral Sclerosis -Wound Healing -Alcoholic Hepatitis
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