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

September 12, 2019 updated by: Allergy and Asthma Consultants, Wichita, Kansas

Allogeneic Transplantation of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Asthma and Allergy Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Duchenne's Muscular Dystrophy

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells
Biological: Umbilical Cord Mesenchymal Stem Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 3 months after final treatment
No occurrence of adverse events
3 months after final treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline of weight
Time Frame: 3 months after final treatment
3 months after final treatment
Change of muscle diameter (circumferential measurements) from baseline
Time Frame: 3 months after final treatment
3 months after final treatment
Change from baseline of Pulmonary Maximum Expiratory Pressure
Time Frame: 3 months after final treatment
3 months after final treatment
Change from baseline of Pulmonary Forced Vital Capacity
Time Frame: 3 months after final treatment
3 months after final treatment
Maximum Change from baseline of Predicted Inspiratory Pressure %
Time Frame: 3 months after final treatment
3 months after final treatment
Change from baseline of Predicted Maximum Expiratory Pressure %
Time Frame: 3 months after final treatment
3 months after final treatment
Change from baseline of Predicted Forced Vital Capacity %
Time Frame: 3 months after final treatment
3 months after final treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergy and Asthma Consultants, Wichita, Kansas

Collaborators

Aidan Foundation
Neil H. Riordan PhD

Investigators

  • Principal Investigator: Maurice HV Strickland, MD, Allergy and Asthma Consultants of Wichita, KS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

September 8, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

September 16, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 16026 DMD Single Patient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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