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2024-516211-25-00RecruitingPhase 1/2

A long-term monitoring study of patients suffering from a malignant neoplasm of the central nervous system previously treated with hematopoietic stem cells

A follow-up study evaluating the long term safety of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 gene previously administered to patients with glioblastoma multiforme

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Next steps

Brief summary (registry, in English)

The primary objective is to evaluate the long term mutagenic safety of Temferon.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
5 (estimated)
First submitted
1 Aug 2024
Start date
27 Oct 2022
Lead sponsor
Genenta Science S.p.A.
Diseases
Glioblastoma
EU CT number
2024-516211-25-00
EudraCT number
2021-000700-38

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 5
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Other

  • There are no exclusion criteria for this study

Who the study is looking for

  • Patients who have received Temferon and completed the follow-up in the TEM-GBM_001 study.
  • Able and willing to provide written informed consent and comply with the study protocol and procedures.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Ospedale San Raffaele S.r.l.MilanItalyRecruiting
IRCCS Foundation Istituto Neurologico Carlo BestaMilanItalyRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.