RecruitingPhase 2NCT03630211

Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis

Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)


Sponsor

Paul Szabolcs

Enrollment

8 participants

Start Date

Jul 31, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a stem cell transplant using a patient's own stem cells (collected, treated, and returned to the patient) can help children, teenagers, young adults, and adults with severe systemic sclerosis (scleroderma), a serious autoimmune disease that causes the immune system to attack and stiffen the skin and internal organs. **You may be eligible if...** - For the children/young adult group: you are between 8 and 24 years old, were diagnosed with systemic sclerosis at or before age 19, and have not responded to at least 2 prior medications - For adults: specific adult criteria apply as defined in the protocol - You have given written informed consent (or your parent/guardian has) **You may NOT be eligible if...** - Your disease has not been confirmed as systemic sclerosis - You have responded well to prior treatments - You have serious organ dysfunction that would make a transplant unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Stem Cell Mobilization

DRUGMesna

Stem Cell Mobilization

DRUGRituximab

Transplantation Conditioning

DRUGAlemtuzumab

Transplantation Conditioning

DRUGThiotepa

Transplantation Conditioning

DRUGGM-CSF

Transplantation Conditioning

DRUGIntravenous immunoglobulin

Transplantation Conditioning

RADIATIONTotal Body Irradiation

Transplantation Conditioning

DRUGAnti Thymocyte Globulin

Transplantation Conditioning


Locations(3)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03630211


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