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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00742300
First received: August 26, 2008
Last updated: November 21, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Autoimmune Diseases
Procedure: Autologous hematopoietic stem cell transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune Reconstitution [ Time Frame: over 24 months ] [ Designated as safety issue: No ]
  • Organ-specific response parameters [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Serological Response (Autoantibodies) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Study Start Date: January 1998
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00742300

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Krukenkamp, Charité Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00742300     History of Changes
Other Study ID Numbers: CT-0198
Study First Received: August 26, 2008
Last Updated: November 21, 2008
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Charite University, Berlin, Germany:
ASCT
Tolerance induction
SLE
Transplantation
Autoimmune diseases

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on September 22, 2014