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
1. 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.