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

Duchenne's Muscular Dystrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235844
• Other study ID #: IND 16026 DMD Single Patient
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: September 30, 2017

Study information

• Verified date: September 2019
• Source: Allergy and Asthma Consultants, Wichita, Kansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 28 Years to 31 Years

Eligibility

Inclusion Criteria:

• Duchenne's Muscular Dystrophy

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Duchenne's Muscular Dystrophy
• Muscular Dystrophies
• Muscular Dystrophy, Duchenne

Intervention

Biological:
• Umbilical Cord Mesenchymal Stem Cells

Locations

Country	Name	City	State
United States	Asthma and Allergy Consultants	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Allergy and Asthma Consultants, Wichita, Kansas	Aidan Foundation, Neil H. Riordan PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	No occurrence of adverse events	3 months after final treatment
Secondary	Change from baseline of weight		3 months after final treatment
Secondary	Change of muscle diameter (circumferential measurements) from baseline		3 months after final treatment
Secondary	Change from baseline of Pulmonary Maximum Expiratory Pressure		3 months after final treatment
Secondary	Change from baseline of Pulmonary Forced Vital Capacity		3 months after final treatment
Secondary	Maximum Change from baseline of Predicted Inspiratory Pressure %		3 months after final treatment
Secondary	Change from baseline of Predicted Maximum Expiratory Pressure %		3 months after final treatment
Secondary	Change from baseline of Predicted Forced Vital Capacity %		3 months after final treatment