A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02174536
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhagic Cystitis; Stem Cell Transplantation; Decidual Stromal Cells	Biological: Decidual stromal cells; Biological: Placebo	Phase 2

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
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Biological: Decidual stromal cells; Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.
Placebo Comparator: 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).	Biological: Placebo

Outcome Measures

Primary Outcome Measures

1. Days to disappearence of macroscopic hematuria or clots [1 month after inclusion]

   Each day, patients fill out a form were they state whether they have macroscopic hematuria or not.

Secondary Outcome Measures

1. Time to disappearance of pain or urges [1 month after inclusion]

2. Time to disappearance of microscopic hematuria [1 month after inclusion]

   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.

3. Transplant related mortality [1 year after inclusion]

   All mortality except relapse

4. Incidence of severe infections [1 year after inclusion]

   Incidence of severe bacterial, viral or fungal infections.

5. Incidence of graft versus host disease [One year after inclusion]

6. Overall actuarial survival [Actuarial]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Stockholm		Sweden	14186

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Olle Ringdén, MD, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Olle Ringdén, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT02174536
• Other Study ID Numbers: DSCHC002
• First Posted: Jun 25, 2014
• Last Update Posted: Jun 25, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Cystitis

Study Results

No Results Posted as of Jun 25, 2014