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Trial record 15 of 157 for:    stem cell arthritis AND Arthritis

Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism

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ClinicalTrials.gov Identifier: NCT00282412
Recruitment Status : Terminated (No participant enrolled for three years. No plan to continue study.)
First Posted : January 26, 2006
Results First Posted : July 30, 2018
Last Update Posted : July 30, 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 Rheumatoid Arthritis
Interventions Biological: Hematopoietic Stem Cell Transplantation
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Campath 1H
Drug: GCSF
Drug: Cyclosporins
Drug: Mycophenolate Mofetil
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA

Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation

Period Title: Overall Study
Started 4
Completed 2 [1]
Not Completed 2
Reason Not Completed
Death             2
[1]
Two late deaths non-treatment related. One from pulmonary embolism and one from late leukemia.
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA

Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
40.00  (12.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
 100.0%
1.Primary Outcome
Title Survival
Hide Description The number of participants who survived treatment
Time Frame up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants who survived treatment
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description:

Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA

Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation

Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
Time Frame Up to 5 years
Adverse Event Reporting Description All adverse events will be collected at 6 months, 1 year and then yearly up to five years
 
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA

Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation

All-Cause Mortality
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%)
Total   2/4 (50.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   2/4 (50.00%)    
Blood and lymphatic system disorders   
Pulmonary embolus  [1]  1/4 (25.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Acute leukemia  [2]  1/4 (25.00%)  1
Indicates events were collected by systematic assessment
[1]
Seven months after the transplant, one participant died from pulmonary embolus. Never developed GVHD
[2]
One patient was in complete remission, RF neg, no GVHD, stable mixed chimerism, died 4 years after treatment from leukemia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   3/4 (75.00%)    
Infections and infestations   
Step bovis infection  [1]  1/4 (25.00%)  1
Urinary tract infection (UTI)  [2]  1/4 (25.00%)  1
Sinus infection  [3]  1/4 (25.00%)  2
Indicates events were collected by systematic assessment
[1]
One participant had positive step bovis infection post-transplant. Pt had 2 previous step bovis infection prior to transplant. GI workup was negative and was cleared for transplant. The source for recurrent step bovis infection is unclear.
[2]
One participant had one episode of UTI treated with oral antibiotic
[3]
One participant reported two sinus infections, one resolved without treatment, and one treated with oral antibiotic.
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
Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00282412     History of Changes
Other Study ID Numbers: DIAD RA ALLO
First Submitted: January 24, 2006
First Posted: January 26, 2006
Results First Submitted: June 8, 2017
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018