Using stem cells to treat digital ulcers in systemic sclerosis
Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial
This study is testing whether injecting stem cells can help people with systemic sclerosis and painful digital ulcers that don't get better with regular treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT03211793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with systemic sclerosis who have active digital ulcers that are resistant to conventional therapies.
Not a fit: Patients with ulcers caused by underlying calcinosis or those with serious concomitant diseases may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing and quality of life for patients suffering from debilitating digital ulcers due to systemic sclerosis.
How similar studies have performed: While the use of mesenchymal stromal cells in other conditions has shown promise, this specific application for digital ulcers in systemic sclerosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Utrecht
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.