Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00504803

Enrollment

Registered

2007-07-20

Start date

2006-12-31

Completion date

2010-12-31

Last updated

2011-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancies

Keywords

HCT, nonmyeloablative, mesenchymal stem cells, GVHD

Brief summary

Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study

Interventions

PROCEDUREMesenchymal stem cell infusion

Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 75 Years

Healthy volunteers

Yes

Inclusion criteria

V.1. Patients V.1.1. Diseases Hematological malignancies confirmed histologically and not rapidly progressing: * AML in CR; * ALL in CR; * CML unresponsive/intolerant to Imatinib but not in blast crisis; * Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis; * MDS with \< 5% blasts; * Multiple myeloma; * CLL; * Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease); * Hodgkin's disease. V.1.2. Clinical situations * Theoretical indication for a standard allo-transplant, but not feasible because: * Age \> 55 yrs; * Unacceptable end organ performance; * Patient's refusal. * Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant. V.1.3. Other inclusion criteria * Male or female; fertile female patients must use a reliable contraception method; * Age \< 75 yrs. * Informed consent given by patient or his/her guardian if of minor age. V.1.4.

Exclusion criteria

* Any condition not fulfilling inclusion criteria; * HIV positive; * Terminal organ failure, except for renal failure (dialysis acceptable); * Uncontrolled infection, arrhythmia or hypertension; * Previous radiation therapy precluding the use of 2 Gy TBI; * HLA-identical donor. V.2. PBSC donors V.2.1. Inclusion criteria * Related to the recipient (sibling, parent or child) or unrelated; * Male or female; * Weight \> 15 Kg (because of leukapheresis); * Fulfills generally accepted criteria for allogeneic PBSC donation; * Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures. V.2.2.

Design outcomes

Primary

Measure	Time frame
Day-100 incidence of non-relapse mortality	100 days

Secondary

Measure	Time frame
1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution	365 days

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026