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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Charite University, Berlin, Germany.
Recruitment status was:  Active, not recruiting
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: August 26, 2008
Last updated: November 21, 2008
Last verified: November 2008
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: 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 ]
  • Overall Survival [ Time Frame: 24 months ]

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

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)


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

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
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Please refer to this study by its identifier: NCT00742300

Charité Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
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 automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Christoph Krukenkamp, Charité Universitätsmedizin Berlin Identifier: NCT00742300     History of Changes
Other Study ID Numbers: CT-0198
Study First Received: August 26, 2008
Last Updated: November 21, 2008

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

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists processed this record on June 23, 2017