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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


Phase 1/Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Autoimmune Diseases

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Renate Arnold, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charite University, Berlin, Germany

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

CT-0198

NCT ID:

NCT00742300

Start Date:

January 1998

Completion Date:

Related Keywords:

  • Autoimmune Diseases
  • ASCT
  • Tolerance induction
  • SLE
  • Transplantation
  • Autoimmune diseases
  • Autoimmune Diseases

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