Using stem cells to treat digital ulcers in systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MANUS Trial investigates the safety and potential effectiveness of injecting allogeneic mesenchymal stromal cells into patients with systemic sclerosis who have painful digital ulcers that do not respond to standard treatments. This randomized, double-blind, placebo-controlled trial will involve 20 participants who will receive either the stem cell treatment or a placebo in their most affected limb. The primary focus is on assessing local toxicity and adverse events within 12 weeks post-treatment, while secondary outcomes will evaluate healing rates, pain levels, and quality of life improvements.

Why it matters

Who can join: the full rules

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

Where it's running

• Universitair Medisch Centrum Utrecht
  Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Marianne Verhaar, MD, PhD — UMC Utrecht
• Study coordinator: Femke van Rhijn, MD
• Email: f.c.c.brouwer-3@umcutrecht.nl
• Phone: 0031887557329

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.