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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02235844
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Aidan Foundation
Neil H. Riordan PhD
Information provided by (Responsible Party):
Allergy and Asthma Consultants, Wichita, Kansas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Duchenne's Muscular Dystrophy Biological: Umbilical Cord Mesenchymal Stem Cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Transplantation of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for a Single Male Patient With Duchenne Muscular Dystrophy (DMD)
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal Stem Cells
Umbilical Cord Mesenchymal Stem Cells
 Biological: Umbilical Cord Mesenchymal Stem Cells


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 months after final treatment ]
    No occurrence of adverse events


Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   28 Years to 31 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Duchenne's Muscular Dystrophy

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235844


Locations
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United States, Kansas
Asthma and Allergy Consultants
Wichita, Kansas, United States, 67205
Sponsors and Collaborators
Allergy and Asthma Consultants, Wichita, Kansas
Aidan Foundation
Neil H. Riordan PhD
Investigators
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Principal Investigator: Maurice HV Strickland, MD Allergy and Asthma Consultants of Wichita, KS
More Information
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Responsible Party: Allergy and Asthma Consultants, Wichita, Kansas
ClinicalTrials.gov Identifier: NCT02235844    
Other Study ID Numbers: IND 16026 DMD Single Patient
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Allergy and Asthma Consultants, Wichita, Kansas:
Mesenchymal
Stem Cells
Umbilical Cord
Duchenne's
Muscular Dystrophy
Additional relevant MeSH terms:
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Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked