Myelodysplastic Syndrome Clinical Trial
— HPDSCOfficial title:
A Single-Arm Study to Assess the Safety of Transplantation With Human Placental-Derived Stem-Cells Combined With Unrelated and Related Cord Blood in Subjects With Certain Malignant Hematologic Diseases and Non-Malignant Disorders
Verified date | October 2022 |
Source | New York Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical trial is to investigate the safety of human placental-derived stem cells (HPDSC) given in conjunction with umbilical cord blood (UCB) stem cells in patients with various malignant or nonmalignant disorders who require a stem cell transplant. Patients will get either full dose (high-intensity) or lower dose (low intensity) chemo- and immunotherapy followed by a stem cell transplantation with UCB and HPDSC.
Status | Completed |
Enrollment | 43 |
Est. completion date | September 2022 |
Est. primary completion date | June 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 55 Years |
Eligibility | Inclusion Criteria: - < 55 years of age - Life expectancy greater than 3 months - Lansky performance status = 50% (children) or Karnofsky performance status = 70% (adults) or ECOG performance status 0-2 (adults) - DLCO > 50 percent predicted - Left ventricular ejection fraction > 40% estimated - Creatinine clearance or estimated GFR . 60 mL/min/1.73m2 - Serum bilirubin < 1.5x upper limit of normal - Transaminases < 3x upper limit of normal - Absence of uncontrolled infection - HIV negative Exclusion Criteria: - Fanconi Anemia - Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities - Uncontrolled infection - Pregnant or breast-feeding females - Received other investigational agents within 30 days prior to the start of the conditioning regimen |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Colorado | Denver | Colorado |
United States | University of Utah | Salt Lake City | Utah |
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
New York Medical College |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | to evaluate the safety of human placental-derived stem cells (HPDSC) administered in conjunction with umbilical cord blood (UCB) stem cells in patients with malignant and non-malignant diseases. | 100 days | |
Secondary | donor chimerism | donor chimerism will be assessed at set timepoints | 1 year | |
Secondary | engraftment | 1 year | ||
Secondary | Survival | 100 days and 180 days | ||
Secondary | Relapse | 100 days and 180 days | ||
Secondary | Mortality | 1 year |
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