Hemorrhagic CystitisPhase 1/2NCT02172963
A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
A Phase 1/2 study testing Decidual Stromal Cell therapy in people with Hemorrhagic Cystitis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is 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
- Hemorrhagic Cystitis
- What is being tested?
- Decidual Stromal Cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2011to Dec 2013
- 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
- Hemorrhagic cystitis grade 2-4
Who cannot join
- Urinary urge without macroscopic hematuria or clots
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.
Read the detailed description
Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.
- Conditions
- Hemorrhagic Cystitis
- Being tested
- Decidual Stromal Cell therapy
- Keywords
- Stem Cell Transplantation, Decidual Stromal Cells
- Medical subject headings
- Cystitis, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decidual Stromal Cell therapyBiological
Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Decidual Stromal Cell therapy for Hemorrhagic Cystitis | Experimental | Not described Receives: Biological: Decidual Stromal Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response at day 28 after onset of hemorrhagic cystitis
Disappearance of macroscopic hematuria.
Measured: 28 days after inclusion
Secondary outcomes (6)
Actuarial survival at one year after onset of hemorrhagic cystitis
Measured: One year after inclusion
Time to disappearance of pain or urges
Measured: Up to 6 months after inclusion
Time to disappearance of microscopic hematuria
Measured: Up to 84 days after inclusion
Transplant related mortality
All mortality except for relapse
Measured: Up to one year after inclusion
Incidence of severe infections
Incidence of severe bacterial, viral or fungal infections.
Measured: Up to one year after inclusion
Incidence of graft versus host disease
Measured: Up to one year 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 startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic CystitisStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olle Ringdén, Karolinska Institutet
- Investigators
- Olle Ringdén, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172963
- Sponsor's protocol ID
- DSCHC001
- Status last verified
- Jun 2014
- First submitted
- 18 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
- ClinicalTrials.gov ID
- NCT02172963
- Acronym / sponsor ID
- DSCHC001
- Conditions
- Hemorrhagic Cystitis
- Keywords
- Stem Cell Transplantation, Decidual Stromal Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- 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 placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.
Detailed description
Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decidual Stromal Cell therapy for Hemorrhagic Cystitis | Experimental | Biological: Decidual Stromal Cell therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hemorrhagic cystitis grade 2-4
Key exclusion criteria (1 listed)
- Urinary urge without macroscopic hematuria or clots
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 |
|---|---|---|
| Decidual Stromal Cell therapyIntravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg. | Biological | Decidual Stromal Cell therapy for Hemorrhagic Cystitis |
Primary outcome
Response at day 28 after onset of hemorrhagic cystitis
Time frame: 28 days after inclusion
Disappearance of macroscopic hematuria.
6 secondary outcomes
Actuarial survival at one year after onset of hemorrhagic cystitis
Time frame: One year after inclusion
Time to disappearance of pain or urges
Time frame: Up to 6 months after inclusion
Time to disappearance of microscopic hematuria
Time frame: Up to 84 days after inclusion
Transplant related mortality
Time frame: Up to one year after inclusion
Incidence of severe infections
Time frame: Up to one year after inclusion
Incidence of graft versus host disease
Time frame: Up to one year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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 Decidual Stromal Cell therapy in people with Hemorrhagic Cystitis, 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 1 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: finished, as of the sponsor's last update on 24 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response at day 28 after onset of hemorrhagic cystitis (time frame: 28 days 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 24 Jun 2014.