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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

Mesenchymal Stromal Cells for Angiogenesis and Neovascularisation in Digital Ulcers of Systemic Sclerosis: the MANUS Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The MANUS Trial aims to examine the safety, feasibility and potential efficacy of intramuscularly injected allogeneic mesenchymal stromal cells as treatment for digital ulcers of systemic sclerosis.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Mesenchymal stromal cells

8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).

OTHER

Placebo

8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).

Locations (1)

Universitair Medisch Centrum Utrecht
Utrecht, Netherlands