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completed

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

key information

study id #: NCT02235844

condition: Duchenne's Muscular Dystrophy

status: completed

purpose:

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.

intervention: Umbilical Cord Mesenchymal Stem Cells

mechanism of action: Stem cells to control inflammation and promote regeneration

results: https://clinicaltrials.gov/ct2/show/results/NCT02235844

last updated: September 23, 2019

study details

start date: September 2014

estimated completion: September 30, 2017

phase of development: Phase 1

size / enrollment: 1

primary outcomes:

  • Adverse Events [Time Frame: 3 months after final treatment]
    No occurrence of adverse events

secondary outcomes:

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

inclusion criteria:

• Eligible Sexes:

• Duchenne's Muscular Dystrophy

exclusion criteria:
• None

study contacts

sponsor: Allergy and Asthma Consultants, Wichita, Kansas

investigators: Maurice HV Strickland, MD

trial center locations: United States