Graft-Versus-Host DiseasePhase 1NCT01522716
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
A Phase 1 study testing Mesenchymal stromal cells in people with Graft-Versus-Host Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft-Versus-Host Disease
- What is being tested?
- Mesenchymal stromal cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2011to Mar 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
- Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects
Who cannot join
- Active malignancy
- Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Hematology Center, Karolinska University Hospital Huddinge
Stockholm
About this study
The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.
- Conditions
- Graft-Versus-Host Disease
- Being tested
- Mesenchymal stromal cells
- 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.
Mesenchymal stromal cellsBiological
Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stromal cell treatment | Experimental | Not described Receives: Biological: Mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity according to National Institute of Health criteria
Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.
Measured: Baseline to 9 months
Secondary outcomes (4)
Change in disease activity as measured by histological examination
Measured: Baseline to 9 months
Change in self-assessed disease activity and quality of life
Measured: Baseline to 9 months
Safety (Adverse events, infections and relapse)
Frequency of complications, infections and relapse
Measured: 21 months
Freedom from steroids at 1 year after MSC treatment
Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment.
Measured: 1 year after finishing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startAug 2011
- Primary completionMar 2016
- Study completionMar 2017
Why it stopped: New requirements for study approval with the Swedish Medical Products Agency
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Lena von Bahr, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522716
- Sponsor's protocol ID
- MSC-cGVH
- Status last verified
- Nov 2020
- First submitted
- 24 Jan 2012
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Boberg E, von Bahr L, Afram G, Lindstrom C, Ljungman P, Heldring N, Petzelbauer P, Garming Legert K, Kadri N, Le Blanc K. Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study. Stem Cells Transl Med. 2020 Oct;9(10):1190-1202. doi: 10.1002/sctm.20-0099. Epub 2020 Jun 23.
PubMed 32573983
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease
- ClinicalTrials.gov ID
- NCT01522716
- Acronym / sponsor ID
- MSC-cGVH
- Conditions
- Graft-Versus-Host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New requirements for study approval with the Swedish Medical Products Agency
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Aug 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Feb 2012 (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.
The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stromal cell treatment | Experimental | Biological: Mesenchymal stromal cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR
- Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects
Key exclusion criteria (2 listed)
- Active malignancy
- Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease
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 |
|---|---|---|
| Mesenchymal stromal cellsAllogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months. | Biological | Mesenchymal stromal cell treatment |
Primary outcome
Change in disease activity according to National Institute of Health criteria
Time frame: Baseline to 9 months
Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score.
4 secondary outcomes
Change in disease activity as measured by histological examination
Time frame: Baseline to 9 months
Change in self-assessed disease activity and quality of life
Time frame: Baseline to 9 months
Safety (Adverse events, infections and relapse)
Time frame: 21 months
Freedom from steroids at 1 year after MSC treatment
Time frame: 1 year after finishing treatment
Results and safety
The study was stopped early (reason given: New requirements for study approval with the Swedish Medical Products Agency). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 32573983Boberg E, von Bahr L, Afram G, Lindstrom C, Ljungman P, Heldring N, Petzelbauer P, Garming Legert K, Kadri N, Le Blanc K. Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study. Stem Cells Transl Med. 2020 Oct;9(10):1190-1202. doi: 10.1002/sctm.20-0099. Epub 2020 Jun 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal stromal cells in people with Graft-Versus-Host Disease, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Nov 2020. 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 Sweden. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: New requirements for study approval with the Swedish Medical Products Agency). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity according to National Institute of Health criteria (time frame: Baseline to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01522716, which also lists 1 linked publication.
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 25 Nov 2020.