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Autologous Hematopoietic Stem Cell Transplantation for Refractory Autoimmune Diseases (ASTRAD)

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ClinicalTrials.gov Identifier: NCT00742300
Recruitment Status : Unknown
Verified November 2008 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2008
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
Charite University, Berlin, Germany

Study Description
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Brief Summary:
While glucocorticoids and immunosuppressants ameliorate manifestations of autoimmune diseases in many patients, current therapies are insufficient to control the disease in a subset of patients, and their clinical prognosis remains poor due to the development of vital organ failure, cumulative drug toxicity and to the increased risk of cardiovascular disease and malignancy. Immunoablative chemotherapy followed by autologous hematopoietic stem cell transplantation (ASCT) has recently emerged as a promising experimental therapy for severely affected patients, providing them the potential to achieve treatment-free, long-term remission. The rationale for applying ASCT to autoimmune diseases has been the hope that immunoablation could eliminate inflammation-driving pathogenic cells from the immune system, and that regeneration of the patients' immune system from hematopoietic precursors could re-establish immunological tolerance.

Condition or disease Intervention/treatment Phase
Autoimmune Diseases Procedure: Autologous hematopoietic stem cell transplantation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Open-Label Monocentric Clinical Trial for Induction of Tolerance With CD34-Enriched Autologous Hematopoietic Stem Cell Transplantation After High-Dose Chemotherapy With Cyclophosphamide and Rabbit-Antithymocyte Globulin for Refractory Autoimmune Diseases
Study Start Date : January 1998

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Treatment Group
 Procedure: Autologous hematopoietic stem cell transplantation
Transplantation of CD34-selected autologous hematopoietic stem cells after high-dose chemotherapy with cyclophosphamide (200mg/kg) and rabbit-antithymocyteglobulin (90mg/kg)
Other Names:
  • Mobilization: 2.0 g/m2 Cyclophosphamide followed by daily G-CSF (10 µg/kg, Amgen, Thousand Oaks, CA)
  • Conditioning: 200mg/kg Cyclophosphamide (Endoxan), 90mg/kg rabbit-antithymocyteglobulin (ATG, Fresenius, Bad Homburg, Germany)
  • Stem cell selection: CliniMACS Device (Miltenyi Biotec, Bergisch Gladbach, Germany)


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 24 months ]
  2. Overall Survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Immune Reconstitution [ Time Frame: over 24 months ]
  2. Organ-specific response parameters [ Time Frame: 24 months ]
  3. Serological Response (Autoantibodies) [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Autoimmune disease
  • Active disease with inadequate response to standard protocols (glucocorticoids and at least two different regimens of immunosuppressive drugs, such as intravenous cyclophosphamide 800-1000mg/application)
  • Provision of informed consent by subject

Exclusion Criteria:

  • Active or chronic infections
  • Uncontrolled arrhythmia or congestive heart failure (ejection fraction below 50% determined by echocardiogram)
  • Lung fibrosis (transfer factor for carbon monoxide [TLCO] <45%)
  • renal insufficiency (glomerular filtration rate below 40 ml/min)
  • Pulmonary arterial hypertension (>40mmHg)
  • History of malignancy
  • Women who are pregnant or breastfeeding
  • Use non-reliable methods of contraception
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742300


Locations
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Germany
Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Renate Arnold, Prof. Dr. med. Charite University, Berlin, Germany
Study Chair: Falk Hiepe, Prof. Dr. med. Charite University, Berlin, Germany
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christoph Krukenkamp, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00742300    
Other Study ID Numbers: CT-0198
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008
Keywords provided by Charite University, Berlin, Germany:
ASCT
Tolerance induction
SLE
Transplantation
Autoimmune diseases
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists