Graft-Versus-Host DiseasePhase 1/2MSCGVHDNCT00749164
Allogeneic Mesenchymal Stem Cell for Graft-Versus-Host Disease Treatment
A Phase 1/2 study testing MSC transplantation in people with Graft-Versus-Host Disease, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- MSC transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Aug 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. 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.
- 3. 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).
- 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.
- 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.
- 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.
- Termination of all GvHD medications other than cyclosporine/tacrolimus/MMF and prednisolone is strongly encouraged.
Who cannot join
- Patients with poor performance, not expected to survive 5 days.
- Patients with a history of hypersensitivity to penicillin and/or gentamycine
- Poor compliance.
- Donor inclusion criteria:
- MSC donor must be HIV, HB-s antigen, anti HBc and anti HCV negative.
- First choice original HSC donor HLA-identical sibling donor.
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- 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 exclusion criteria:
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Mesenchymal Stem Cell Infusion for Treatment Of Steroid Resistant GVHD
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
- Conditions
- Graft-Versus-Host Disease
- Being tested
- MSC transplantation
- Keywords
- Mesenchymal stem cells, Umbilical cord, graft-vs-host disease, Steroid resistant
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC transplantationProcedure or surgery
1-2X10^6 MSC per kg
What is being measured
The primary outcome is the main question the study is designed to answer.
GVHD re-staging and/or GVHD mortality ,side effects
Measured: within the first 30 days (plus or minus 3 days) after MSC transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startSep 2009
- Primary completionFeb 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Prof. Igor B Resnick, MD, PhD, DSci, Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749164
- Sponsor's protocol ID
- IBR-0137-08-HMO-CTIL
- Acronym
- MSCGVHD
- Status last verified
- Aug 2009
- First submitted
- 14 Jul 2008
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Mesenchymal Stem Cell Infusion for Treatment Of Steroid Resistant GVHD
- ClinicalTrials.gov ID
- NCT00749164
- Acronym / sponsor ID
- MSCGVHD / IBR-0137-08-HMO-CTIL
- Conditions
- Graft-Versus-Host Disease
- Keywords
- Mesenchymal stem cells, Umbilical cord, graft-vs-host disease, Steroid resistant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. 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.
- 3. 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).
- 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.
- 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.
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSC transplantation1-2X10^6 MSC per kg | Procedure or surgery | – |
Primary outcome
GVHD re-staging and/or GVHD mortality ,side effects
Time frame: within the first 30 days (plus or minus 3 days) after MSC transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Igor B Resnick, MD, PhD, DSci principal investigator
Hadassah University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MSC transplantation in people with Graft-Versus-Host Disease, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof. Igor B. Resnick, MD, PhD, DSci (972-2-6778353, gashka@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GVHD re-staging and/or GVHD mortality ,side effects (time frame: within the first 30 days (plus or minus 3 days) after MSC transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009.