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Hematopoietic Stem Cell Therapy for Patients With Refractory Myasthenia Gravis

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ClinicalTrials.gov Identifier: NCT00424489
Recruitment Status : Terminated (No participants enrolled for more than two years. No plan to continue study.)
First Posted : January 19, 2007
Results First Posted : August 6, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Myasthenia Gravis
Interventions: Biological: Hematopoietic Stem Cell Transplantation
Drug: Cyclophosphamide
Drug: ATG (rabbit)
Drug: Mesna
Drug: Methylprednisolone
Drug: G-CSF

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Hematopoietic Stem Cell Transplantation

Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning

Hematopoietic Stem Cell Transplantation: Autologous Hematopoietic Stem Cell Transplantation


Participant Flow:   Overall Study
    Hematopoietic Stem Cell Transplantation
STARTED   9 
COMPLETED   6 
NOT COMPLETED   3 
Death                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hematopoietic Stem Cell Transplantation

Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning

Hematopoietic Stem Cell Transplantation: Autologous Hematopoietic Stem Cell Transplantation


Baseline Measures
   Hematopoietic Stem Cell Transplantation 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      1  11.1% 
Between 18 and 65 years      8  88.9% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.22  (16.49) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  44.4% 
Male      5  55.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   9 


  Outcome Measures

1.  Primary:   Survival   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small numbers of subjects enrolled


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Richard Burt
Organization: Northwestern University
phone: 312-695-4960
e-mail: rburt@northwestern.edu



Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00424489     History of Changes
Other Study ID Numbers: Myasthenia Gravis Auto 2002
First Submitted: January 18, 2007
First Posted: January 19, 2007
Results First Submitted: June 20, 2017
Results First Posted: August 6, 2018
Last Update Posted: August 31, 2018