Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||8 Years - 25 Years|
Inclusion Criteria:1. Age 8 ≤ 25 years at time of enrollment. 2. Severe systemic sclerosis or systemic lupus erythematosus based on specific criteria. 3. Adequate organ function status. 4. No active, untreated infections.
Exclusion Criteria:1. Previous hematopoietic stem cell transplant (HSCT) or solid organ transplant. 2. Pregnancy. 3. Ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs (DMARD) 4. Severe comorbidity that jeopardizes the ability of the subject to tolerate therapy
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Stephan Grupp MD PhD|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Caitlin Elgarten, MD|
|Principal Investigator Affiliation||Children's Hospital of Philadelphia|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Systemic Lupus Erythematosus, Systemic Sclerosis|
Experimental: CD3/CD19 depleted ASCT
The test article is autologous stem cell transplant with a CD3/CD19-depleted stem cell product.
Biological: - Depletion of CD3/CD19 in an autologous stem cell transplant
The purpose of this study is to determine the safety and feasibility of CD3/CD19 depleted autologous stem cell transplant for the treatment of life threatening autoimmune disease. We will perform CD3/CD19 depletion using the CliniMACs device as a means of purging autoreactive T and B cells from the transfused autologous stem cell product, while retaining some immune function, namely natural killer cells and monocytes in the product.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.