Mesenchymal Stromal Cells as Treatment for Digital Ulcers in Systemic Sclerosis

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht
• Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development

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