A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Karolinska Institutet
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Days to disappearence of macroscopic hematuria or clots
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hemorrhagic cystitis grade 2-4
- •Receives Misoprostol therapy
Exclusion Criteria
- •Patients with urinary urge without macroscopic hematuria or clots
Arms & Interventions
Decidual Stromal cell therapy
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.
Intervention: Decidual stromal cells (Biological)
Placebo
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).
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time to disappearance of pain or urges(1 month after inclusion)
- Time to disappearance of microscopic hematuria(1 month after inclusion)
- Transplant related mortality(1 year after inclusion)
- Incidence of severe infections(1 year after inclusion)
- Incidence of graft versus host disease(One year after inclusion)
- Overall actuarial survival(Actuarial)
Investigators
Olle Ringdén
Professor
Karolinska Institutet