NCT02235844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

3.1 years

First QC Date

September 8, 2014

Last Update Submit

September 12, 2019

Conditions

Duchenne's Muscular Dystrophy

Keywords

MesenchymalStem CellsUmbilical CordDuchenne'sMuscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    No occurrence of adverse events

    3 months after final treatment

Secondary Outcomes (7)

  • Change from baseline of weight

    3 months after final treatment

  • Change of muscle diameter (circumferential measurements) from baseline

    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

  • Maximum Change from baseline of Predicted Inspiratory Pressure %

    3 months after final treatment

  • +2 more secondary outcomes

Study Arms (1)

Mesenchymal Stem Cells

EXPERIMENTAL

Umbilical Cord Mesenchymal Stem Cells

Biological: Umbilical Cord Mesenchymal Stem Cells

Interventions

Umbilical Cord Mesenchymal Stem CellsBIOLOGICAL
Mesenchymal Stem Cells

Eligibility Criteria

Age28 Years - 31 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Duchenne's Muscular Dystrophy

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma and Allergy Consultants

Wichita, Kansas, 67205, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, DuchenneMuscular Dystrophies

Condition Hierarchy (Ancestors)

Muscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Maurice HV Strickland, MD

    Allergy and Asthma Consultants of Wichita, KS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 10, 2014

Study Start

September 1, 2014

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations

US(1)