Hematopathy
Conditions
Interventions
MSC treatment group:MSC treatment
Sponsors
the First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
No minimum to 50 Years
Inclusion criteria
Inclusion criteria: From December 2013 to December 2021, 300 patients with allogeneic hematopoietic stem cell transplantation (including siblings, haplotypes, unrelated HSCT, and umbilical cord blood transplantation) were enrolled in this project. Hemorrhagic cystitis (HC) occurs during or after hematopoietic reconstitution after hematopoietic stem cell transplantation, but hematuria caused by urinary tract bacterial infection or systemic hematological diseases must be excluded. [ HC classification standard divides HC into grade I to IV: Class I: microscopic hematuria, Class II: naked hematuria, Class III: naked hematuria with blood clots, Class IV: Urinary retention due to removal of blood clots or blood clots with instruments or surgical intervention. Class III-IV HC belongs to severe HC. Umbilical cord-derived mesenchymal stem cells (UCMSCs) are used to treat grade III-IV hemorrhagic cystitis or I-II hemorrhagic cystitis who are ineffective or progressively aggravated by traditional treatment. Participants suitable for this study must meet all the following criteria: 1. Aged less than 50 years, gender and race are not limited; 2. All patients with malignant hematological diseases diagnosed by MICM (in accordance with WHO diagnostic criteria), including acute myeloid leukemia (AML, except APL), acute lymphocytic leukemia (ALL) and acute mixed cell leukemia (MAL), myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML), myelodysplastic syndrome/myeloproliferative tumors. (MDS/MPN) and malignant lymphoma; all patients had indications of allogeneic hematopoietic stem cell transplantation; 3. Both of them used myeloablative pretreatment or enhanced myeloablative pretreatment; 4. Karnofsky score (> 60%) and the physical condition score of Eastern Cancer Cooperative Group (ECOG) was 0-2 (Annex 1); 5. Within 2 weeks before admission, the upper limit of serum total bilirubin (< the same age group) was 1.5 times; the upper limit of ALT and AST (< the same age group) was 3 times; the upper limit of serum creatinine (< the same age group) was 2 times; and the upper limit of myocardial enzyme (< the same age group) was 2 times; 6. Negative anti-HIV test; 7. Each subject must sign an informed consent (ICF) indicating that he or she understands the purpose and procedure of the study and is willing to participate in the study. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the ICF shall be signed by the legal representative.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria are not eligible for this study: 1. Patients who had previously undergone hematopoietic stem cell transplantation; 2. Have any serious complications (such as pulmonary infection, etc.) or accompanying diseases (such as uncontrolled diabetes mellitus, etc.); 3. Those with serious organ dysfunction or disease, such as heart, liver, kidney and pancreas; 4. Pregnancy patients; 5. Researchers believe that any life-threatening disease, physical condition or organ system dysfunction that impairs the safety of subjects and exposes the results of research to unnecessary risks; drug addicts; uncontrolled mental patients; cognitive impairments; 6. Subjects and/or authorized family members who refuse to undergo allogeneic hematopoietic stem cell transplantation; 7. Participate in other clinical researchers within 3 months; 8. Researchers believe that it is not suitable for patients to be enrolled in the group (such as those who are expected to be unable to adhere to treatment due to financial problems).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urine routine;Serum creatinine; | — |
Countries
China
Contacts
Public ContactZimin Sun
the First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed