Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Launched by UMC UTRECHT · Jul 5, 2017

Keywords

ClinConnect Summary

The MANUS Trial is a clinical study that is looking into a new treatment for digital ulcers caused by systemic sclerosis, a condition that affects the skin and connective tissues. Researchers want to find out if injecting special cells called mesenchymal stromal cells can help heal these painful ulcers. This trial is currently recruiting participants who are between the ages of 65 and 74 and have at least one active digital ulcer that hasn’t improved with standard treatments.

To be eligible for the trial, participants must have a confirmed diagnosis of systemic sclerosis and have at least one ulcer that has not healed despite receiving intravenous prostacyclins (a type of medication). Those interested will need to provide informed consent and may need to undergo some screening tests to ensure they meet the criteria. Participants can expect to receive the cell injections and will be monitored closely for safety and effectiveness throughout the study. It’s important to note that certain health conditions and recent medical history may disqualify someone from participating, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Established diagnosis of SSc according to the 2013 ACR/EULAR criteria
• • At least one active digital ulcer (painful area, \>2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins
• • 'Refractory to prostacyclins' is defined as
• • Worsening of ulcer(s) within 1 month after prostacyclins iv
• • No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged by the referring physician
• • Recurrence of exactly the same ulcer(s) (same location) within 3 months after prostacyclins iv
• • Written informed consent
• Exclusion Criteria:
• • Ulcer with underlying calcinosis (ruled out by X-ray prior to screening/inclusion)
• • History of neoplasm or malignancy in the past 10 years
• • Pregnancy or unwillingness to use adequate contraception during study
• • Serious known concomitant disease with life expectancy \<1 year
• • Uncontrolled hypertension
• • Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever)
• • Follow-up impossible