Mesenchymal stem cell infusion as prevention for graft rejection and graft-versus-host disease after allogeneic hematopoietic cell transplantation with nonmyeloablative conditioning: a pilot study - NA

• Conditions: Patients with hematological malignancies not candidate for conventional allogeneic transplantation because of age or comorbidities.; MedDRA version: 8.1Level: LLTClassification code 10027703Term: Mismatched donor bone marrow transplantation therapy

• Registration Number: EUCTR2006-004101-26-BE
• Lead Sponsor: CHU Sart-Tilman

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patient
1. Hematological malignancies confirmed histologically and not rapidly progressing.
2. Theoretical indication for a standard allo-transplant, but not feasible because:
Age > 55 yrs; Unacceptable end organ performance; Patient’s refusal. OR
Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.
3. Male or female; fertile female patients must use a reliable contraception method;
4 Age 5 Informed consent given by patient or his/her guardian if of minor age.
6 HLA-compatibility with HSC or cord blood donor as described in the protocol

Donor
1 Related to the recipient (sibling, parent or child) or unrelated;
2 Fulfills generally accepted criteria for allogeneic PBSC donation;
3 Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.

Are the trial subjects under 18? yes
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient
1 Any condition not fulfilling inclusion criteria;
2 HIV positive;
3 Terminal organ failure, except for renal failure (dialysis acceptable);
4 Uncontrolled infection, arrhythmia or hypertension;
5 Previous radiation therapy precluding the use of 2 Gy TBI;
6 HLA-identical donor.

Donor

1 Any condition not fulfilling inclusion criteria;
2 HIV positive;
3 Unable to undergo leukapheresis because of poor vein access or other reasons.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified