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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hematological Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

MSC co-infusion with either HLA-mismatched PBSC or cord blood

Group Type EXPERIMENTAL

Mesenchymal stem cell infusion

Intervention Type PROCEDURE

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

Interventions

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Mesenchymal stem cell infusion

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

Intervention Type PROCEDURE

Other Intervention Names

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Mesenchymal stem cells

Eligibility Criteria

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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.

* 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

* 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.

* HIV positive;
* Unable to undergo leukapheresis because of poor vein access or other reasons.

V.2.3. HLA matching

Related or unrelated donors who have 1-2 HLA mismatches, as either :

* One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
* One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
* Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
* One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
* One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1

V.3. Cord blood unit

Banked cord blood units will be used if they fulfill the following criteria:

* No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)
* \> 2.5 x 107 TNC/kg
* Standard validation by FACT/Netcord criteria.

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes