mbilical cord blood transplantation in high-risk hematological patients using stemregenin-1 expanded hematopoietic stem cells.A feasibility study focussing on engraftment and hematopoietic recovery.

Phase 1

Conditions: Patients with high-risk hematological diseases, who need a allogeneicstem cell transplantation but who lack a matched unrelated donor
MedDRA version: 19.0Level: PTClassification code 10061187Term: Haematopoietic neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-002383-13-NL

Lead Sponsor: Erasmus MC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Age 18-70 years inclusive
- Diagnosis of poor-risk hematological malignancy or (V)SAA relapsing after or failing immunosuppressive therapy and meeting the criteria for a MUD allo SCT
- Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required time period of = 2 months in case of urgently needed alloSCT
- Availability of 1 (=5/6) matched UCB graft with a nuclear cell count > 2,7 x 107/kg (see paragraph 8.2).
- Availability of an back-up autograft, harvested and frozen earlier in the course of treatment, (harvest according to local aphersis policies)
- WHO performance status 0-2
- Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

• Bilirubin and/or transaminases > 2.5 x normal value
• Creatinine clearance < 40 ml/min
• Cardiac dysfunction as defined by:
-Reduced left ventricular function with an ejection fraction < 45% as measured by MUGA scan or echocardiogram (another method for measuring cardiac function is acceptable)
- Unstable angina
- Unstable cardiac arrhythmias
• Pulmonary function test with VC, FEV1 and/ or DCO < 50%
• Active, uncontrolled infection
• History of high dose (= 8 Gy) total body irradiation
• Pregnant or lactating females
• HIV positivity