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news.Aldagen has announced that the first patient has been treated in a Phase III clinical trial for ALD-101, which is being developed to improve cord blood transplants used to treat inherited metabolic diseases in pediatric patients.
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The company commenced the Phase III clinical trial of ALD-101 to evaluate its ability to accelerate neutrophil and platelet engraftment following cord blood transplantation in these patients. ALD-101 is a population of adult stem cells isolated from cord blood using Aldagen’s proprietary technology.
In this Phase III trial, 40 pediatric patients with inherited metabolic diseases undergoing a cord blood transplant will be treated. The primary goal of the study is to determine if ALD-101 can accelerate the restoration of circulating platelets.
A 24-patient Phase I/II study of ALD-101 was previously conducted and a statistically significant reduction in the time to platelet engraftment was observed in patients receiving ALD-101 as part of a cord blood transplant compared to patients who had received a cord blood transplant without ALD-101 in an earlier independent clinical trial.