{
    "info": {
        "nct_id": "NCT01479582",
        "official_title": "A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have maximum age of 99 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION CRITERIA:\n\nPatients with FDA-specified indications:\n\n* Hematological malignancies\n* Certain lysosomal storage and peroxisomal enzyme deficiency disorders\n* Hurler syndrome (MPS I)\n* Krabbe Disease (Globoid Leukodystrophy)\n* X-linked Adrenoleukodystrophy\n* Primary immunodeficiency diseases\n* Bone marrow failure\n* Beta-thalassemia\n* Signed informed consent (and signed assent, if applicable)\n* Pediatric and adult patients of any age\n\nEXCLUSION CRITERIA:\n\n* Patients who are receiving only licensed CBUs\n* Cord blood transplant recipients at international transplant centers"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Patients with FDA-specified indications:",
            "criterions": [
                {
                    "exact_snippets": "FDA-specified indications",
                    "criterion": "FDA-specified indications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematological malignancies",
            "criterions": [
                {
                    "exact_snippets": "Hematological malignancies",
                    "criterion": "hematological malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Certain lysosomal storage and peroxisomal enzyme deficiency disorders",
            "criterions": [
                {
                    "exact_snippets": "lysosomal storage ... enzyme deficiency disorders",
                    "criterion": "lysosomal storage enzyme deficiency disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "peroxisomal enzyme deficiency disorders",
                    "criterion": "peroxisomal enzyme deficiency disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hurler syndrome (MPS I)",
            "criterions": [
                {
                    "exact_snippets": "Hurler syndrome (MPS I)",
                    "criterion": "Hurler syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Krabbe Disease (Globoid Leukodystrophy)",
            "criterions": [
                {
                    "exact_snippets": "Krabbe Disease (Globoid Leukodystrophy)",
                    "criterion": "Krabbe Disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* X-linked Adrenoleukodystrophy",
            "criterions": [
                {
                    "exact_snippets": "X-linked Adrenoleukodystrophy",
                    "criterion": "X-linked Adrenoleukodystrophy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Primary immunodeficiency diseases",
            "criterions": [
                {
                    "exact_snippets": "Primary immunodeficiency diseases",
                    "criterion": "primary immunodeficiency diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bone marrow failure",
            "criterions": [
                {
                    "exact_snippets": "Bone marrow failure",
                    "criterion": "bone marrow failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Beta-thalassemia",
            "criterions": [
                {
                    "exact_snippets": "Beta-thalassemia",
                    "criterion": "Beta-thalassemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed informed consent (and signed assent, if applicable)",
            "criterions": [
                {
                    "exact_snippets": "Signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "signed assent, if applicable",
                    "criterion": "assent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "applicability",
                            "expected_value": "if applicable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pediatric and adult patients of any age",
            "criterions": [
                {
                    "exact_snippets": "Pediatric and adult patients of any age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "any"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are receiving only licensed CBUs",
            "criterions": [
                {
                    "exact_snippets": "receiving only licensed CBUs",
                    "criterion": "CBU licensing",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "licensed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cord blood transplant recipients at international transplant centers",
            "criterions": [
                {
                    "exact_snippets": "Cord blood transplant recipients",
                    "criterion": "cord blood transplant",
                    "requirements": [
                        {
                            "requirement_type": "recipient status",
                            "expected_value": "recipient"
                        }
                    ]
                },
                {
                    "exact_snippets": "international transplant centers",
                    "criterion": "transplant center location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "international"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA:",
            "criterions": []
        }
    ]
}