Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04356755 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

Study acronym: ADUSE
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2025 to Mar 2027v7
  2. Trial status: Suspended to Recruiting Primary and study completion dates: Dec 2023 to Dec 2025 · Interventions: Adipose tissue harvest (Procedure), Autologous ASC (Drug), Placebo (Drug) to AdMSC (Drug), Placebo (Drug) · Study description shortened, about 7 words · 2 morev6 Show 5 more changesShow less
    • Primary and study completion dates: Dec 2023 to Dec 2025
    • Interventions: Adipose tissue harvest (Procedure), Autologous ASC (Drug), Placebo (Drug) to AdMSC (Drug), Placebo (Drug)
    • Study description shortened, about 7 words
    • Site details revised at 7 of 7 sites
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Suspended Sponsor's reason: covid-19 Primary and study completion dates: Mar 2023 to Dec 2023 · Site details revised at 7 of 7 sitesv5 Show 2 more changesShow less
    • Primary and study completion dates: Mar 2023 to Dec 2023
    • Site details revised at 7 of 7 sites
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 7 · Start date changed from estimate of Sep 2020 to Sep 22, 2020v3 Show 2 more changesShow less
    • Study sites: 1 to 7
    • Start date changed from estimate of Sep 2020 to Sep 22, 2020
  6. Start date: May 2020 to Sep 2020v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ischemic digital ulcers (DUs) are a frequent complication in systemic sclerosis with a major impact on hand function and quality of life. Digital injection of cultured adipose-derived stromal cell (AdMSC) constitutes a promising approach to treat scleroderma-induced refractory ischemic DUs where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of digital injection of AdMSC versus placebo for healing refractory active ischemic digital ulcers in patients with systemic sclerosis.
Trial Details
NCT Number NCT04356755
Lead Sponsor University Hospital, Toulouse
Conditions Systemic Sclerosis
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov