Phase 2 Peripheral Neuropathy 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:

• Adults between 18 and 80 years old
• People who have been diagnosed with type 2 diabetes according to 2023 American Diabetes Association diagnostic standards
• People who have signs of nerve damage in their lower limbs — either at least one abnormal result from specific nerve tests (ankle reflexes, pin-prick feeling, vibration, pressure, or temperature sensing) along with symptoms like numbness, pain, or tingling; or at least two abnormal results from those same tests even without symptoms
• People whose nerve function tests show slowed nerve signals in at least one nerve in the lower leg (confirm with trial site for specific nerve tested)
• People with a moderate to severe level of nerve damage, measured by a scoring system called the Toronto Clinical Scoring System (TCSS), with a score of 9 or higher
• People whose symptoms have not improved enough (less than a 2-point drop in their TCSS score) despite at least 3 months of standard treatment
• People who are able to understand the study and are willing to follow all study procedures, and who have signed a consent form

Who may not be able to join:

• People whose leg nerve problems or pain appear to be caused by something other than diabetes, as judged by the treating doctor
• People whose diabetes is poorly controlled, specifically those with a blood sugar marker (HbA1c) above 12%
• People with serious problems affecting their blood, liver, or kidneys — including low white blood cell or platelet counts, low haemoglobin, abnormal liver enzyme levels, poor kidney function, or elevated muscle enzyme levels (confirm specific cut-off values with trial site)
• People with a known allergy to stem cells, stem cell products, or any ingredients used in stem cell treatments
• People who have recently taken certain prohibited medications and have not waited long enough since stopping them (confirm with trial site)
• People with uncontrolled serious ongoing illnesses, such as severe active infections, serious autoimmune conditions, blood disorders, or significant heart failure
• People whose heart rhythm shows a clinically significant abnormality on an ECG (heart tracing) test
• People who have a condition in their leg or foot — such as severe diabetic foot ulcers — that would prevent a local stem cell injection from being performed
• People with other conditions considered unsuitable for trial participation, including active cancer, significant memory or thinking difficulties, depression, or other mental health conditions
• People who have taken part in another interventional clinical trial within the 3 months before screening
• People who are pregnant, breastfeeding, or planning to become pregnant within 2 years
• People whom the treating doctor considers unsuitable for the trial for any other reason

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