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Gene Therapy

Gene Therapy

Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be...

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Related Experiment Video

Updated: Jan 12, 2026

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers

Published on: March 3, 2023

Anatomically Directed Lower Extremity Gene Therapy for Ulcer Healing: A Double-Blind, Randomized, Placebo-Controlled

David G Armstrong¹, Michael S Conte², Joseph L Mills³

¹Department of Surgery, Keck School of Medicine of the University of Southern California, Los Angeles (D.G.A.).

Circulation. Cardiovascular Interventions

|November 4, 2025

Summary

This summary is machine-generated.

AMG0001, a novel therapy for chronic limb-threatening ischemia, significantly accelerated wound healing in patients with neuroischemic ulcers. This approach offers a promising nonsurgical option for this underserved patient population.

Keywords:

hemodynamics oxygen plasmids ulcer wound healing

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Published on: April 7, 2016

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Last Updated: Jan 12, 2026

Prospective, Randomized, and Controlled Study of a Human Umbilical Cord Mesenchymal Stem Cell Injection for Treating Diabetic Foot Ulcers

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Adenoviral Gene Therapy for Diabetic Keratopathy: Effects on Wound Healing and Stem Cell Marker Expression in Human Organ-cultured Corneas and Limbal Epithelial Cells

Adenoviral Gene Therapy for Diabetic Keratopathy: Effects on Wound Healing and Stem Cell Marker Expression in Human Organ-cultured Corneas and Limbal Epithelial Cells

Published on: April 7, 2016

Area of Science:

Vascular Medicine
Regenerative Medicine
Clinical Trials

Background:

Chronic limb-threatening ischemia (CLTI) lacks FDA-approved therapies for wound healing, presenting a significant unmet medical need.
Existing biologic studies in CLTI often focus on end-stage patients with amputation-free survival as the primary outcome.
This trial investigated AMG0001, a plasmid encoding hepatocyte growth factor (HGF), for promoting ulcer healing in CLTI patients.

Purpose of the Study:

To evaluate the efficacy of intramuscular AMG0001 in promoting ulcer healing in patients with CLTI and neuroischemic ulcers.
To assess the safety and effectiveness of AMG0001 compared to placebo.
To determine the optimal dosage and timing for AMG0001 administration.

Main Methods:

The LEGenD-1 trial was a double-blind, randomized, placebo-controlled Phase II study at 22 US sites.
Seventy-five participants with neuroischemic ulcers and specific perfusion criteria were randomized to AMG0001 (4 mg or 8 mg) or placebo.
Intramuscular injections were administered along a guided artery path on days 0, 28, 56, and 84.

Main Results:

Median time to complete ulcer healing was significantly shorter with AMG0001 versus placebo (84 vs. 280 days; P=0.007).
By 6 months, 63.3% of AMG0001-treated participants achieved healing compared to 38.5% with placebo (P=0.053).
Healing rates at 12 months were 77.6% for AMG0001 versus 46.2% for placebo (P=0.010), with similar adverse events across groups.

Conclusions:

Anatomically targeted intramuscular delivery of AMG0001 significantly accelerated healing in patients with moderate CLTI and neuroischemic ulcers.
AMG0001 represents a promising nonsurgical therapeutic strategy for CLTI-related wound healing.
Further investigation into AMG0001 could lead to new treatment options for patients with CLTI.