Pilot study of bone marrow-derived mesenchymal stem cells for the treatment of refractory hemorrhagic cystitis occurring after hematopoietic stem cell transplantation

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002826

Enrollment

Registered

2018-04-24

Start date

2019-01-10

Completion date

Unknown

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Each dose contains 1x106 cells/kg (patient&#39

Biological/Vaccine, Stem Cell : Bone marrow derived mesenchymal stem cells

s weight) and is intravenously administered. One week after the first administration, a second dose can be administered depending on the patient&#39

s clinical improvement. Only a maximum of two doses can be given.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Confirmed hemorrhagic cystitis patient occurring after allogeneic or autologous hematopoietic stem cell transplantation 2) Patients with ECOG performance status rating of 0, 1, or 2 3) Patients who are considered to be able to survive for 3 months or more 4) Patients without evidence of acute infectious disease 5) Patients who have no evidence of accompanying tumor

Exclusion criteria

Exclusion criteria: 1) Pregnant, lactating women or women who have the possibiity of being pregnant or who have not taken adequate contraceptive 2) Patients with active infection or fever with unknown etiology or ongoing bacterial or fungal infection 3) ECOG performance status of 3 or 4 4) Patients with previously confirmed HIV infection, uncontrolled hypertension (diastolic blood pressure > 115mmg Hg), unstable angina, congestive heart failure (NY class II or higher), poorly controlled severe diabetes, coronary angioplasty within 6 months, Patients with acute myocardial infarction or non-malignant disease including uncontrolled atrial or ventricular arrhythmia within the last 6 months 5) Patients with mental illnesses,drug addiction, etc. who are judged to have an influence on the outcome of the study 6) Patients participating in other clinical trials (but, subject to the clinical judgment of the investigator) 7) Patients who are judged to be inadequate due to the judgment of the person in charge of clinical trial (principal investigator) 8) Patients with other serious medical conditions that may reduce compliance with clinical trials

Design outcomes

Primary

Measure	Time frame
Safety: physical examination, chest x-ray, EKG, blood chemistry, blood test, adverse event evaluation, ECOG performance evaluation, Assessment of quality of life	—

Secondary

Measure	Time frame
Efficacacy: urine test, immunological analyses	—

Countries

Korea, Republic of

Contacts

Public ContactNayoun Kim

The Catholic University of Korea

Outcome results