Phase 2 Peripheral Arterial Disease Trial, Recruiting

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

Who might be able to join this trial:

Cohort 1 — Children, Adolescents and Young Adults:

• Written consent must be provided by the patient, parent, or legal guardian, and patients aged 16 or older who are developmentally able will also be asked to give their agreement
• People aged 8 to 24 years old at the time of joining the study
• People who were diagnosed with Systemic Sclerosis (a disease that affects the skin and internal organs) at age 19 or younger
• People whose disease has not improved or has gotten worse while taking at least 2 different disease-modifying medications within the past 12 months, and who also have at least one of the following: worsening skin thickening in the past 6 months or a high skin thickening score; worsening lung disease in the past 18 months shown by scans or breathing tests; muscle inflammation shown by blood tests or MRI; a low childhood muscle function score; joint inflammation; or open sores at the fingertips
• People who have received clearance from a heart specialist to undergo a stem cell transplant, as recorded in their medical file
• People who have tested negative for HIV, hepatitis B, and hepatitis C, confirmed by PCR blood tests
• Females who have started their periods must have a negative pregnancy test
• Females who could become pregnant and sexually active males must agree to use an FDA-approved form of contraception for up to 24 months after the bone marrow transplant, or for as long as they are taking any medication that could harm a pregnancy or cause birth defects

Cohort 2 — Adults:

• Written consent must be provided by the patient, and patients aged 16 or older who are developmentally able will also be asked to give their agreement
• People aged 18 to 55 years old at the time of joining the study (note: patients up to age 24 who were diagnosed with SSc at age 19 or younger would be assessed under Cohort 1 instead)
• People who have been diagnosed with Systemic Sclerosis according to the 2013 international classification criteria
• People who meet specific criteria related to either skin involvement or lung disease, as follows: for skin involvement — having widespread skin thickening that started less than 2 years ago with a calculated intermediate or high risk score, OR skin thickening of more than 2 years with evidence of worsening skin score or detectable tendon friction; for lung disease — having recognised scarring on a lung scan from less than 2 years ago with significant lung involvement or reduced lung function, OR lung scarring of any duration with a meaningful decline in lung function over the past 12–18 months
• People who have tested negative for HIV, hepatitis B, and hepatitis C, confirmed by PCR blood tests
• Females must have a negative pregnancy test
• Females who could become pregnant and sexually active males must agree to use an FDA-approved form of contraception for up to 24 months after the bone marrow transplant, or for as long as they are taking any medication that could harm a pregnancy or cause birth defects

Who may not be able to join:

Cohort 1 — Children, Adolescents and Young Adults:

• People whose lung breathing capacity (FVC) is below 35% of the expected level, as measured by breathing tests (where the person is able to complete the test adequately)
• People whose blood oxygen level at rest in normal air is below 92%
• People whose kidneys are not filtering blood well enough, based on a standard calculation using body weight
• People currently experiencing an active, untreated kidney crisis related to their Systemic Sclerosis
• People with liver enzyme levels (ALT) more than 4 times the normal upper limit
• People with an active, uncontrolled infection that would make it unsafe to receive high-dose immune-suppressing treatment
• People with abnormal blood counts, specifically: too few white blood cells (a type called neutrophils), too few platelets, or low haemoglobin (a sign of anaemia)
• People who have had cancer within the past 2 years, with some exceptions for certain skin cancers that have been fully treated and in confirmed remission or cure for at least 2 years
• People with any other medical condition or finding that the investigator believes could increase risk, interfere with study participation, or affect the quality of the study results

Cohort 2 — Adults:

• People with moderate to severe heart problems, including any of the following: significant heart failure; reduced heart pumping function below 50% on cardiac MRI; high blood pressure in the lungs above specific thresholds (which differ depending on age); certain abnormal heart rhythms lasting 1 minute or more, or currently being treated for them; a specific type of fast heart rhythm in the lower chambers; certain types of electrical conduction problems in the heart shown on an ECG; or having a pacemaker or implantable heart device
• People with moderate to severe lung problems, including any of the following: gas transfer capacity below 45%; breathing capacity (FVC) below 45%; low oxygen or high carbon dioxide levels in the blood (for adults aged 18 and over); blood oxygen below 92% at rest without extra oxygen (for adults aged 18 and over); or being unable to walk at least 400 feet in a six-minute walk test
• People who have been taking steroid medications (such as prednisone) above specified doses within the 30 days before the start of the treatment preparation phase, or who have taken high-dose steroids for other conditions on multiple occasions in the past 6–12 months
• People whose kidneys are not filtering blood well enough, based on a standard calculation using body weight
• People with a blood creatinine level above 2.0 mg/dL, indicating reduced kidney function
• People currently experiencing an active, untreated kidney crisis related to their Systemic Sclerosis
• People who depend on tube feeding or IV nutrition
• People with an active stomach or gut blood vessel condition (GAVE) causing a significant drop in haemoglobin in the past 60 days
• People with active liver inflammation shown by elevated liver enzymes (AST, ALT, or bilirubin) above specified thresholds
• People with evidence of moderate to severe scarring around the liver, confirmed by liver biopsy if one has been done
• People with an active, uncontrolled infection that would make it unsafe to receive high-dose immune-suppressing treatment
• People with abnormal blood counts, specifically: too few white blood cells (a type called neutrophils), too few platelets, or low haemoglobin (a sign of anaemia)
• People with evidence of a bone marrow disorder called myelodysplasia, confirmed by bone marrow testing if applicable
• People who have had cancer within the past 2 years, with some exceptions for certain skin cancers or hormonal therapy for breast cancer, where treatment has been fully completed with confirmed remission or cure for at least 2 years
• Females who are pregnant or breastfeeding
• People who have used tobacco products within the 4 weeks before joining the study
• People with a known sensitivity or allergy to proteins derived from mice or E. coli bacteria
• People with a known history of substance misuse within the 6 months before joining the study
• People who have had a serious allergic reaction to anti-thymocyte globulin or similar preparations made from horse proteins
• People with any other medical condition or finding that the investigator believes could increase risk, interfere with study participation, or affect the quality of the study results

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