Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function

  • STATUS
    Recruiting
  • days left to enroll
    40
  • participants needed
    100
  • sponsor
    University of Liege
Updated on 7 April 2022
tacrolimus
cyclosporine
granulocyte colony stimulating factor
transplant conditioning
autologous transplantation
neutrophil count
acute graft-versus-host disease
Accepts healthy volunteers

Summary

The present project aims at investigating the role of MSC for the treatment of patients with

Part 1: Steroid-refractory grade II-IV acute GVHD.

Part 2: Poor graft function (PGF)

Part 3: Low or falling donor T-cell chimerism after allogeneic HCT.

This is a multicenter phase II study examining the feasibility and efficacy of this approach.

Description

Part 1: complete recruitment Part 2: complete recruitment Part 3: recruiting

Details
Condition Graft-versus-host Disease, Poor Graft Function, Low Donor T-cell Chimerism
Treatment Mesenchymal stem cells, Mesenchymal stem cells
Clinical Study IdentifierNCT00603330
SponsorUniversity of Liege
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient eligibility criteria
Male or female of any age
Previous allogeneic transplantation (related or unrelated donor, any degree of HLA matching) or autologous transplantation (for part 2 only) of HSC at any time before
Any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen
Informed consent given by donor or his/her guardian if of minor age
Additional criteria for each part of the protocol
Part 1: MSC for steroid-refractory grade II-IV acute GVHD
Allogeneic transplantation
Grade II-IV acute GVHD (see appendix A for acute GVHD grading) de novo or following DLI
Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent, defined as
progression of GVHD on day 3 after initiation of steroids
no improvement of GVHD on day 7 after initiation of steroids
absence of complete resolution of acute GVHD on day 14 after initiation of steroids
relapse of acute GVHD during or after steroid taper
Ongoing therapy with Ciclosporine or Tacrolimus at therapeutic doses
Patient may have received previously any other form of treatment for acute GVHD, but no new treatment started within 1 month of study entry
Part 2: MSC for poor graft function (PGF)
Allogeneic or autologous transplantation
Cytopenia in 2 or 3 lineages
Hb < 8.0 g/dL and reticulocytes < 1%, with or without transfusion
Plt < 20,000/µL without transfusion
Neutrophils < 500/µL, without G-CSF administration
OR severe cytopenia in 1 lineage
RBC transfusion dependent (if autologous transplantation; despite EPO administration if allogeneic transplantation)
Plt transfusion dependent
Neutrophils < 500/µL despite G-CSF administration 3. Cytopenia duration ≥ 2 weeks beyond day 28 after autologous HCT, or day 42 (day 60 for
cord blood transplantation) after allogeneic HCT
Part 3: MSC + DLI for poor donor T-cell chimerism
\. Cytopenia is not related to CMV or other infection, myelosuppressive/toxic
Nonmyeloablative allogeneic transplantation
drugs
Donor T-cell chimerism < 50% for at least 2 consecutive weeks beyond day 21 after HCT OR
renal failure, peripheral cell destruction or other identifiable cause
% decrease in donor T-cell chimerism with the second value < 50%
\. In case of HLA-identical related donor and full donor chimerism, patient
MSC donor inclusion criteria
can only be
Related to the recipient (sibling, parent or child) or unrelated
included if a boost of donor CD34+ cells has been unsuccessful or is not
Male or female
feasible
Age > 16 yrs (no age limit if same as HSC donor)
No HLA matching required
Fulfills generally accepted criteria for allogeneic HSC donation
Informed consent given by donor or his/her guardian if of minor age

Exclusion Criteria

Patient exclusion criteria
HIV positive
Active uncontrolled infection at time of scheduled MSC infusion
Relapsing or progressing malignancy
MSC donor exclusion criteria
HIV positive
Known allergy to Lidocaine
If donor other than HSC donor : any risk factor for transmissible infectious diseases
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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