Human Placental-Derived Stem Cell Transplantation

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Brief Title

Human Placental-Derived Stem Cell Transplantation

Official 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

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Safety

Secondary Outcome

 donor chimerism

Condition

Mucopolysaccharidosis I

Intervention

Human Placental Derived Stem Cell

Study Arms / Comparison Groups

 Group A
Description:  related cord blood with ≥3/6 HLA match to the patient and related HPDSC

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

43

Start Date

April 2013

Completion Date

December 2020

Primary Completion Date

June 2019

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - 55 Years

Accepts Healthy Volunteers

No

Contacts

Mitchell S Cairo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01586455

Organization ID

NYMC 550

Secondary IDs

NYMC IRB L-10,733

Responsible Party

Sponsor

Study Sponsor

New York Medical College


Study Sponsor

Mitchell S Cairo, MD, Principal Investigator, New York Medical College


Verification Date

February 2020