Graft vs Host DiseasePhase 1/2NCT02172924
A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
A Phase 1/2 study testing Early Decidual stromal cell therapy and Late Decidual stromal cell therapy in people with Graft vs Host Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Graft vs Host Disease
- What is being tested?
- Early Decidual stromal cell therapy and Late Decidual stromal cell therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2017to Dec 2019
- 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
- Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
- Are on calcineurin inhibitor and high dose corticosteroids.
Who cannot join
- Terminally ill patients
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet
Stockholm, 14186
Olle Ringdén, MD, PhD, +858582672, olle.ringden@ki.se
Olle Ringdén, MD, PhD
About this study
The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.
Read the detailed description
Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
- Conditions
- Graft vs Host Disease
- Being tested
- Early Decidual stromal cell therapy, Late Decidual stromal cell therapy
- Keywords
- Stem Cell Transplantation, Decidual 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.
Early Decidual stromal cell therapyBiological
Intervention given within 7 days after corticosteroids.
Late Decidual stromal cell therapyBiological
Intervention given after 7 days after corticosteroids.
| Study group | Role | What they receive |
|---|---|---|
| Early Decidual Stromal Cells | Active comparator | Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids since no more than 7 days will be given Decidual Stromal Cell therapy. Receives: Biological: Early Decidual stromal cell therapy |
| Late Decidual Stromal Cells | Active comparator | Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy. Receives: Biological: Late Decidual stromal cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actuarial survival at one year after onset of graft versus host disease
Measured: 12 months after inclusion
Secondary outcomes (4)
Response at 28 days after onset of graft versus host disease
Measured: 28 days after inclusion
Side effects
Measured: Up to 6 months after inclusion
Incidence of severe infections
Measured: Up to 12 months after inclusion
Disease free survival
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital
- Responsible party
- Principal investigator, Olle Ringdén, Karolinska Institutet
- Investigators
- Olle Ringdén, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172924
- Sponsor's protocol ID
- DSCGVHD001
- Status last verified
- Nov 2014
- First submitted
- 17 Jun 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT02172924
- Acronym / sponsor ID
- DSCGVHD001
- Conditions
- Graft vs Host Disease
- Keywords
- Stem Cell Transplantation, Decidual Stromal Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital
- Study start
- Jan 2017
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 24 Jun 2014 (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 purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.
Detailed description
Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Decidual Stromal Cells | Active comparator | Biological: Early Decidual stromal cell therapyPatients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids since no more than 7 days will be given Decidual Stromal Cell therapy. |
| Late Decidual Stromal Cells | Active comparator | Biological: Late Decidual stromal cell therapyPatients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
- Are on calcineurin inhibitor and high dose corticosteroids.
Key exclusion criteria (1 listed)
- Terminally ill patients
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 |
|---|---|---|
| Early Decidual stromal cell therapyIntervention given within 7 days after corticosteroids. | Biological | Early Decidual Stromal Cells |
| Late Decidual stromal cell therapyIntervention given after 7 days after corticosteroids. | Biological | Late Decidual Stromal Cells |
Primary outcome
Actuarial survival at one year after onset of graft versus host disease
Time frame: 12 months after inclusion
4 secondary outcomes
Response at 28 days after onset of graft versus host disease
Time frame: 28 days after inclusion
Side effects
Time frame: Up to 6 months after inclusion
Incidence of severe infections
Time frame: Up to 12 months after inclusion
Disease free survival
Time frame: 12 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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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.
Olle Ringdén, MD, PhD principal investigator
Karolinska Institutet
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 Early Decidual stromal cell therapy and Late Decidual stromal cell therapy in people with Graft vs 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 1 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 Nov 2014. 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 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 Olle Ringdén, MD, PhD (+46858582672, olle.ringden@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actuarial survival at one year after onset of graft versus host disease (time frame: 12 months after inclusion). 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 Nov 2014.