Hemorrhagic CystitisPhase 2NCT02174536
A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
A Phase 2 study testing Decidual stromal cells in people with Hemorrhagic Cystitis and Stem Cell Transplantation, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhagic Cystitis, Stem Cell Transplantation, Decidual Stromal Cells
- What is being tested?
- Decidual stromal cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2014to Dec 2016
- Phase
- Phase 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
- Receives Misoprostol therapy
Who cannot join
- Patients with urinary urge without macroscopic hematuria or clots
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, Stockholm County, 14186
Olle Ringdén, MD, PhD, +46858582672, olle.ringden@ki.se
Olle Ringdén, MD, PhD
About this study
A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.
Read the detailed description
Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.
- Being tested
- Decidual stromal cells, Placebo
- 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 cellsBiological
Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Decidual Stromal cell therapy | Active comparator | Decidual stromal cell therapy (approximately 1x10^6 cells/kg) for hemorrhagic cystitis in addition to Misoprostol therapy (0,2mg, 3 times/day) on two occasions at weekly intervals. Receives: Biological: Decidual stromal cells |
| Placebo | Placebo comparator | Receives placebo (masked i.v. infusion, same amount as an infusion of decidual stromal cells) in addition to Misoprostol therapy (0,2mg, 3 times/day). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to disappearence of macroscopic hematuria or clots
Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.
Measured: 1 month after inclusion
Secondary outcomes (6)
Time to disappearance of pain or urges
Measured: 1 month after inclusion
Time to disappearance of microscopic hematuria
Each day patients, with the help of a urinary test stick, fill out a form were they state whether they have microscopic hematuria or not.
Measured: 1 month after inclusion
Transplant related mortality
All mortality except relapse
Measured: 1 year after inclusion
Incidence of severe infections
Incidence of severe bacterial, viral or fungal infections.
Measured: 1 year after inclusion
Incidence of graft versus host disease
Measured: One year after inclusion
Overall actuarial survival
Measured: Actuarial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
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
- NCT02174536
- Sponsor's protocol ID
- DSCHC002
- Status last verified
- Jun 2014
- First submitted
- 23 Jun 2014
- Last updated
- 25 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
- ClinicalTrials.gov ID
- NCT02174536
- Acronym / sponsor ID
- DSCHC002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 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.
A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.
Detailed description
Patients with grade 2-4 hemorrhagic cystitis will be randomized to receive either decidual stromal cell therapy at approximately 1x106 cells/kg or placebo on two occasions at weekly intervals. Patients not responsive within 2 weeks will receive decidual stromal cells at approximately 1x106 cells/kg openly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decidual Stromal cell therapy | Active comparator | Biological: Decidual stromal cellsDecidual stromal cell therapy (approximately 1x10^6 cells/kg) for hemorrhagic cystitis in addition to Misoprostol therapy (0,2mg, 3 times/day) on two occasions at weekly intervals. |
| Placebo | Placebo comparator | Biological: PlaceboReceives placebo (masked i.v. infusion, same amount as an infusion of decidual stromal cells) in addition to Misoprostol therapy (0,2mg, 3 times/day). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hemorrhagic cystitis grade 2-4
- Receives Misoprostol therapy
Key exclusion criteria (1 listed)
- Patients with 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 cellsDecidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously. | Biological | Decidual Stromal cell therapy |
| Placebo | Biological | Placebo |
Primary outcome
Days to disappearence of macroscopic hematuria or clots
Time frame: 1 month after inclusion
Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.
6 secondary outcomes
Time to disappearance of pain or urges
Time frame: 1 month after inclusion
Time to disappearance of microscopic hematuria
Time frame: 1 month after inclusion
Transplant related mortality
Time frame: 1 year after inclusion
Incidence of severe infections
Time frame: 1 year after inclusion
Incidence of graft versus host disease
Time frame: One year after inclusion
Overall actuarial survival
Time frame: Actuarial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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 2 study testing Decidual stromal cells in people with Hemorrhagic Cystitis and Stem Cell Transplantation, 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 25 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. Some participants in this study may receive a placebo. 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 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?
Days to disappearence of macroscopic hematuria or clots (time frame: 1 month 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 25 Jun 2014.