Taking people in ItalyPhase 1/2
Long-term safety follow-up of gene-modified stem cell therapy in glioblastoma patients
Monitors long-term safety of Temferon, a gene-modified stem cell treatment, in adults with glioblastoma.
Key facts
- Who runs it
- Genenta Science S.p.A.
- Where
- Milan, ItalySee the 2 sites
- Registry title
- A long-term monitoring study of patients suffering from a malignant neoplasm of the central nervous system previously treated with hematopoietic stem cells
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 5 people, planned
- Started
- 27 Oct 2022
- Expected to end
- 30 Apr 2027
- Type of study
- Interventional
- Record updated
- 26 August 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with glioblastoma who already received Temferon in the TEM-GBM_001 study and finished its follow-up. It checks long-term safety.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Glioblastoma multiforme (GBM), treated earlier with Temferon.
- Earlier treatment
- Must have received Temferon and finished the follow-up in the TEM-GBM_001 study.
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- There are no exclusion criteria for this study
Where in Italy
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
About the trial
What the trial wants to find out
The primary objective is to evaluate the long term mutagenic safety of Temferon.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Long-term safety follow-up of gene-modified stem cell therapy in glioblastoma patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 26 August 2024