NCT00749164

Brief Summary

Now it is commonly accepted that MSC produce an immune-tolerant environment in different settings. It has been shown (mainly for BM-MSC) that MSC can down-regulate T cells activation. This characteristic of BM derived MSC already has clinical implications and shows their potent effectiveness both in prophylaxis and treatment of resistant GvHD. Ongoing clinical trials of use bone marrow MSC for treatment of steroid resistant GvHD are successfully run on and some bone marrow donor registries included BM-MSC as a material for donation. According to our preclinical studies MSC from cells from marrow, placenta, umbilical cord vessels demonstrate similar pronounced immunosuppressive effect both with autologous and allogeneic lymphocytes. Our preliminary clinical experience shows that BM-MSC is an effective tool for treatment of steroid resistant GVHD. Present study aimed to demonstrate if human UC-MSC has in vivo immunosuppressive effect and can be used for GVHD treatment

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

2.4 years

First QC Date

July 14, 2008

Last Update Submit

August 10, 2009

Conditions

Graft-Versus-Host Disease

Keywords

Mesenchymal stem cellsUmbilical cordgraft-vs-host diseaseSteroid resistant

Outcome Measures

Primary Outcomes (1)

  • GVHD re-staging and/or GVHD mortality ,side effects

    within the first 30 days (plus or minus 3 days) after MSC transplantation

Interventions

MSC transplantationPROCEDURE

1-2X10\^6 MSC per kg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. Informed consent. 2. Any patient that has undergone allogeneic stem cell transplantation with steroid refractory grades II-IV acute GvHD either occurring post transplant, or induced by donor lymphocyte infusions (DLI) or T-cell add back. A positive biopsy for GvHD is not required if clinical signs and symptoms are characteristic for GvHD and other etiologies are excluded.
  • \. Patient received best known therapy for GvHD including: i. Patients must receive cyclosporine A (trough level 150-300 ng/ml) or tacrolimus (trough level 5-15 ng/ml).
  • ii. In addition, steroids must have been given, for instance prednisolone ≥2 mg/kg/day (or equivalent doses of methylprednisolone, etc.) for at least 72h in case of progressive acute GvHD, 5 days non progressive acute GvHD.
  • iii. Despite this treatment, the patient has unresponsive GvHD after 5 days or progressive acute GvHD after 72 hours. If single organ acute GvHD grade II from gut or liver, either progression from single organ or addition of one or two more organs; e.g., if the patient has grade II acute GvHD of the skin, GvHD is more intense and more widespread, or GvHD also includes liver and/or gut.
  • iv. Patients with steroid refractory GvHD fulfilling the requirements mentioned in a) - c) may be treated with second line therapy, e.g., MMF, serotherapy, ECP, change of CsA for tacrolimus or vice versa, etc. Failure to respond to additional treatment similar to what is described for steroids in c) is necessary before enrolment in this study.
  • v. Termination of all GvHD medications other than cyclosporine/tacrolimus/MMF and prednisolone is strongly encouraged.

You may not qualify if:

  • Patients with poor performance, not expected to survive 5 days.
  • Patients with a history of hypersensitivity to penicillin and/or gentamycine
  • Poor compliance.
  • MSC donor must be HIV, HB-s antigen, anti HBc and anti HCV negative.
  • First choice original HSC donor HLA-identical sibling donor.
  • Second choice mismatched related or unrelated donor (for instance MSC frozen and left over from another patient).
  • Third choice or emergency pre-expanded third party umbilical cord/placenta derived MSC.
  • Donor more than 65 years of age, or unhealthy.
  • Donor who is positive for HIV, hepatitis Bs antigen, HB-s, anti-HBc and anti HCV negative.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Prof. Igor B Resnick, MD, PhD, DSci

    Hadassah University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Igor B. Resnick, MD, PhD, DSci

CONTACT

972-2-6778353gashka@hadassah.org.il

Dr. Polina Stepensky, MD

CONTACT

972-2-6777408polina@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2008

First Posted

September 9, 2008

Study Start

September 1, 2009

Primary Completion

February 1, 2012

Study Completion

August 1, 2012

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

IL(1)