Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Paul Szabolcs
Study ID
NCT03630211
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Sclerosis Systemic
  • Interstitial Lung Disease
  • Pulmonary Hypertension
  • Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
8 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Stem Cell Mobilization
  • Mesna — DRUG
    Stem Cell Mobilization
  • Rituximab — DRUG
    Transplantation Conditioning
  • Alemtuzumab — DRUG
    Transplantation Conditioning
  • Thiotepa — DRUG
    Transplantation Conditioning
  • GM-CSF — DRUG
    Transplantation Conditioning
  • Intravenous immunoglobulin — DRUG
    Transplantation Conditioning
  • Total Body Irradiation — RADIATION
    Transplantation Conditioning
  • Anti Thymocyte Globulin — DRUG
    Transplantation Conditioning

Study Details

The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment effect.

Key Dates

Start date
Jul 31, 2018
Status verified
Oct 2025
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous Stem Cell Transplantation
    CD34-selected autologous stem cell being performed on CliniMACS depletion device. Conditioning regimen will not start sooner than 3 weeks, and ideally no more than 90 days, after cyclophosphamide dose in the mobilization regimen.

Primary Outcome Measure

High Dose Immunoablative therapy-Safety [ Time Frame: Up to 36 months post HSCT ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15213
Shawna McIntyre, RN
[email protected]
412-692-5552
Paul Szabolcs, MD (PRINCIPAL_INVESTIGATOR)
Robyn Domsic, MD, MPH (SUB_INVESTIGATOR)
Annie Im, MD (SUB_INVESTIGATOR)
Daniel Kass, MD (SUB_INVESTIGATOR)
Geoffrey Kurland, MD (SUB_INVESTIGATOR)
Robert Lafyatis, MD (SUB_INVESTIGATOR)
Adam Olson, MD (SUB_INVESTIGATOR)
Kathryn Torok, MD (SUB_INVESTIGATOR)
Allison Morris, MD, MS (SUB_INVESTIGATOR)
Kirsten Rose-Felker, MD (SUB_INVESTIGATOR)
Franziska Rosser, MD, MPH (SUB_INVESTIGATOR)
Paulina Horvei, MD (SUB_INVESTIGATOR)
Joshua Levenson, MD (SUB_INVESTIGATOR)
Archana Ramgopal, DO (SUB_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15261
Robyn Domsic, MD, MPH
[email protected]
412-383-8000
University of Pittsburgh Medical CenterPittsburghPennsylvania15261
Robert Lafyatis, MD
[email protected]
412-647-6700

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By research site
Children's Hospital of Pittsburgh of UPMC· Pittsburgh, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

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