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Immunosuppressant

Stem Cell Transplant for Lupus

Phase 1

Waitlist Available

Research Sponsored by Northwestern Memorial Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Specific hematologic criteria: Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL, Platelet count less than 40,000/mm3 (without transfusions), Granulocyte count less than 1,000/mm3, Catastrophic anti-phospholipid syndrome

Diagnosis of systemic lupus erythematosus with specific malignant features: Nephritis (WHO class III or IV), Failed NIH short-course cyclophosphamide therapy, Vasculitis/immune complex deposition causing end organ signs or symptoms, Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether a certain combination of drugs is safe for people with lupus.

Who is the study for?

This trial is for patients with severe systemic lupus erythematosus (SLE) showing specific symptoms like serious kidney inflammation, failed previous short-course cyclophosphamide therapy, organ damage due to vasculitis, or certain blood disorders. Participants must have a stable heart function and lung capacity, not be HIV positive or pregnant, and cannot have other major illnesses or mental health conditions that would interfere with the study.Check my eligibility

What is being tested?

The trial tests the safety of wiping out the immune system using high-dose cyclophosphamide and anti-thymocyte globulin followed by support with peripheral blood stem cells in SLE patients. The goal is to see if this approach can reset the immune system to stop it from attacking the body.See study design

What are the potential side effects?

Potential side effects include those related to high-dose chemotherapy such as nausea, hair loss, mouth sores, increased risk of infections due to low white blood cell counts; reactions related to stem cell infusion; and possible allergic reactions to medication components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have lupus with severe kidney issues, unresponsive to specific treatments, or blood problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern Memorial HospitalLead Sponsor

40 Previous Clinical Trials

16,706 Total Patients Enrolled

Ann TraynorStudy ChairNorthwestern Memorial Hospital

Media Library

Anti-thymocyte globulin (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT00017641 — Phase 1

Lupus Clinical Trial 2023: Anti-thymocyte globulin Highlights & Side Effects. Trial Name: NCT00017641 — Phase 1

Anti-thymocyte globulin (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00017641 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapy been given the greenlight by the FDA?

"This experimental treatment scored a 1 due to the fact that this is only in Phase 1, meaning there is limited data available about its safety and effectiveness."

Answered by AI

Who can partake in this medical investigation?

"This clinical trial seeks to recruit 10 people with libman-sacks disease aged between 0 and 59. Eligible candidates must meet the specified Patient Characteristics and Disease Characteristics outlined in the criteria."

Answered by AI

Does your investigation encompass individuals aged 85 and above?

"This medical experiment has established the age range of 0 to 59 as its inclusion criteria. 18 trials are available for minors, while 106 have been designed specifically for patients above 65 years old."

Answered by AI

Are new participants still being enrolled into this experiment?

"As confirmed on clinicaltrials.gov, this medical study has ended enrollment as of June 23rd 2005 and is no longer searching for eligable participants. Despite the closure of this trial, there are still 124 other studies actively looking to recruit new members."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus

2001. "Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00017641.

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