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

Allergy and Asthma Consultants, Wichita, Kansas1 site in 1 country1 target enrollmentSeptember 2014

ConditionsDuchenne's Muscular Dystrophy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Duchenne's Muscular Dystrophy
Sponsor: Allergy and Asthma Consultants, Wichita, Kansas
Enrollment: 1
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2014

End Date

September 30, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Allergy and Asthma Consultants, Wichita, Kansas

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Duchenne's Muscular Dystrophy

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Adverse Events

Time Frame: 3 months after final treatment

No occurrence of adverse events

Secondary Outcomes

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