Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT01305694
Eligibility Criteria:
Inclusion Criteria:
* Patients must fulfill definition of aplastic anaemia:
There must be at least two of the following:
haemoglobin \< 100g/L; platelet count \< 50 x 109/L; neutrophil count \< 1.5 x 109/L, and a hypocellular bone marrow;
SAA as defined by a hypocellular bone marrow of \<25% cellularity and two of the following:
neutrophil count \< 0.5 x 109/L platelets \< 20 x 109/L reticulocytes \< 20 x 109/L nSAA as defined by a hypocellular bone marrow and cytopenia in at least two cell lines and neutrophil count \> 0.5 x 109/L, and red cell and/or platelet transfusion dependence.
* Patients belong to acquired aplastic anaemia.
* Patients with a history SAA must have had an incomplete response at least 3 months following treatment with ATG/CsA, or they must have relapsed following an initial response to treatment, and they do not have a HLA-matched donor for bone marrow transplantation. Patients with a history nSAA must have red cell and/or platelet transfusion dependence.
* Peripheral blood counts at the time of enrollment must include at least one of the following: haemoglobin \< 90 g/L or red blood cell (RBC) transfusion dependence, PMN \< 1 x 109/L, or platelet count \< 50 x 109/L.
* Patients must have organ function as defined below:
total bilirubin within normal institutional limits (NV: 0.0-20.5 umol/L) AST(SGOT)/ALT(SGPT) \< 2.5 × institutional upper limit of normal AST (NV: 0-35 U/L); ALT (NV: 0-40 U/L) Creatinine within normal institutional limits (NV: 53-106 umol/L) or Creatinine clearance \> 1.25 ml/s for patients with creatinine levels above institutional normal.
* Age minimum 16 years old with no upper age limit.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients may not be receiving any other investigational agents within 4 weeks of study entry.
* History of allergic reactions attributed to compounds of similar biologic composition to mesenchymal stem cells.
* Current diagnosis of Fanconi's anemia, Dyskeratosis Congenita (DC) or other hereditary forms of AA.
* Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent.
* Age \< 16 years old.
* ECOG performance status \> 2.
* Malignancy within the last 5 years.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined as invasive fungal infection and progressive CMV viremia), symptomatic congestive heart failure (NYH class III and IV), unstable angina pectoris, or cardiac arrhythmia.
* Pregnant or breastfeeding women.
* HIV-positive patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01305694
Study Brief:
Protocol Section:
NCT01305694