Skip to main content
OpenTrials
Completed

NCT Number: NCT02235844

Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)

This research study is designed to evaluate the effects of human umbilical cord mesenchymal stem cells (UC-MSCs), on Duchenne's muscular dystrophy (DMD). The potential muscle regenerative and anti-inflammatory properties of UC MSCs position them as a possible treatment option for DMD. Both of these properties could lead to potential benefits for a DMD patient.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Duchenne's Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

28 year–31 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Asthma and Allergy Consultants

Wichita, Kansas, 67205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Duchenne's Muscular Dystrophy

Exclusion criteria

  • None

Treatment and study plan

Umbilical Cord Mesenchymal Stem Cells

Biological

Primary outcomes

  1. Adverse Events

    Time frame: 3 months after final treatment

    No occurrence of adverse events

Secondary outcomes

  1. Change from baseline of weight

    Time frame: 3 months after final treatment

  2. Change of muscle diameter (circumferential measurements) from baseline

    Time frame: 3 months after final treatment

  3. Change from baseline of Pulmonary Maximum Expiratory Pressure

    Time frame: 3 months after final treatment

  4. Change from baseline of Pulmonary Forced Vital Capacity

    Time frame: 3 months after final treatment

  5. Maximum Change from baseline of Predicted Inspiratory Pressure %

    Time frame: 3 months after final treatment

  6. Change from baseline of Predicted Maximum Expiratory Pressure %

    Time frame: 3 months after final treatment

  7. Change from baseline of Predicted Forced Vital Capacity %

    Time frame: 3 months after final treatment

Sponsors and collaborators

Lead sponsor

Allergy and Asthma Consultants, Wichita, Kansas

Other

Collaborators

  • Aidan Foundation
  • Neil H. Riordan PhD

Registry information

Official study title

Allogeneic Transplantation of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 10, 2014
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.