Stem Cell Transplant to Treat Patients With Systemic Sclerosis
Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis
2 other identifiers
interventional
24
1 country
1
Brief Summary
Systemic Sclerosis is a disease that may be caused by the immune system reacting against skin and certain organs. It is possible, that by changing the immune system we can modify the progression of this disease. Stem cells are created in the bone marrow. They mature into different types of blood cells that are needed including red blood cells, white blood cells, and platelets. In this study, we will stimulate the bone marrow to make extra stem cells. Next we will collect the stem cells, select specific cells, and store them. We will then give high dose chemotherapy that will destroy the patients immune system. We will then give back the selected stem cells we collected. We believe that these selected stem cells may be able to "re-create" the immune system without the portion that causes Systemic Sclerosis. The purpose of this study is to try to discover if stem cell transplantation can help patients with Systemic Sclerosis. We will also try to learn what the side effects are of this treatment in patients with Systemic Sclerosis. We hope that this treatment will help to relieve the symptoms patients are experiencing, although we do not know if it will.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 1999
Longer than P75 for phase_1
1 active site
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
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
April 8, 2003
CompletedFirst Posted
Study publicly available on registry
April 9, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2004
CompletedJanuary 18, 2020
January 1, 2020
April 8, 2003
January 15, 2020
Conditions
Interventions
Eligibility Criteria
You may not qualify if:
- Patients \> 60 years
- Patients with pulmonary, cardiac, hepatic, or renal impairment which would limit their ability to receive cytoreductive therapy and compromise their survival. This should include patients with any of the following:
- Severe Lung Disease
- Hypoxemia (pO2 £70 mmHg)
- FVC of \< 50%
- DLCO of \< 45%
- Cardiac Disease
- Ejection fraction \< 30%
- Uncontrolled arrhythmias
- Cor. Pulmonale
- Pulmonary hypertension (mPAP \>/=60 mmHg)
- Loss of digits or vascular access secondary to Raynaud's ischemia
- History of oliguric renal failure or episode of renal crisiswith Glomerular filtration rate \< 50ml/min Creatinine. Weight loss \> 20% baseline since first involvement of gastrointestinal tract (midgut); or any patient requiring hyperalimentation prior to transplant because of gut dysfunction related to systemic sclerosis
- SGOT/bilirubin \> 2 x UPN on 2 repeated tests
- Has active uncontrolled infection
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dist Serv Prof, Center for Gene Therapy
Study Record Dates
First Submitted
April 8, 2003
First Posted
April 9, 2003
Study Start
June 1, 1999
Study Completion
June 1, 2004
Last Updated
January 18, 2020
Record last verified: 2020-01