Phase 2 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing to sign a consent form agreeing to take part voluntarily.
• You are between 18 and 65 years old (male or female).
• You have been diagnosed with lupus (SLE) meeting at least 4 out of 11 specific medical criteria, and your disease is currently considered moderately to severely active based on a standard scoring system.
• You have previously tried a combination of treatments for lupus (such as steroids with other medicines), but either could not tolerate them or they did not work well enough.
• You have been diagnosed with a specific type of kidney inflammation caused by lupus (called lupus nephritis, class III or IV, with or without class V), confirmed by a kidney biopsy.
• Your urine tests show a significant amount of protein leaking into your urine, above a certain level (confirm with trial site for exact values).
• You agree not to try to become pregnant or donate sperm or eggs during the trial and for at least 1 year afterward, and you agree to use effective contraception during this time.

Who may not be able to join:

• You have serious liver problems, shown by certain blood test results being more than twice the normal range.
• Your kidneys are functioning very poorly, based on specific blood or lab measurements falling below or above set levels.
• Your kidney biopsy shows that 50% or more of the filtering units in your kidneys are permanently scarred.
• Your blood counts are very low in any of the following areas: white blood cells, red blood cells (causing severe anaemia), platelets, or a specific type of infection-fighting cell called neutrophils.
• You have a serious, uncontrolled condition affecting your heart, lungs, nervous system, liver, hormones (such as uncontrolled diabetes), or digestive system — including very high blood pressure, significant heart failure, a heart attack in the last 6 months, a stroke in the last 6 months, severe high blood pressure in the lungs, or serious heart rhythm problems.
• You have a history of a condition where your immune system does not produce enough of a protein called IgA.
• You have another autoimmune disease in addition to lupus (such as rheumatoid arthritis or systemic sclerosis), although having a secondary condition called Sjögren's syndrome is allowed.
• You have received a live or weakened live vaccine in the past 12 weeks, or expect to need one during the trial.
• You have had a specific blood-cleaning treatment (plasmapheresis or immunoadsorption) in the past 24 weeks, or received a treatment called IVIG in the past 4 weeks.
• You have taken part in another clinical drug trial in the past 12 weeks.
• You have tested positive for HIV, active syphilis, active hepatitis C, or hepatitis B (at certain levels), or you have had a serious or recurring infection recently.
• You have been diagnosed with any cancer in the past 5 years, including blood cancers or tumours in organs (except certain fully treated skin cancers).
• You have had major surgery in the past 12 weeks, or are expected to need major surgery during the trial, which the trial doctor considers too risky.
• You are allergic to the treatment used in this trial (which involves stem cells) or to any of its ingredients, including human albumin; or you cannot take steroid medicines; or you do not have a suitable vein for an intravenous drip.
• You are currently pregnant or breastfeeding.
• In the past 12 months, you have smoked 5 or more cigarettes a day on average, regularly drunk more than 14 units of alcohol per week, or have used illegal drugs or tested positive on a drug screening test.
• The trial doctor has decided for any other reason that the trial may not be suitable for you (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.