Summary
Chronic heart failure is a life-threatening disease usually without cure and a leading cause of morbidity and mortality. In Germany 45 000 patients (projected to EU: about 140 000) die every year from progressive chronic cardiac insufficiency. There is no curative therapeutic solution, except very rare donor hearts and artificial hearts as bridge devices.
Researchers at the Charité - University Medicine, have identified unique cardiac-specific stromal cells (CardAP cells) with strong efficacy in cardiac stress models. CardAP cells are specialized heart-derived cells with key advantages in safety and efficacy.
CardAP cells fulfil all criteria for cardiac cell therapy and cell product manufacturing has been transferred to GMP facilities. CellServe, a Charité spin off, will develop the CardAP cells for therapy of patients suffering from severe life-threatening cardiomyopathy.
CellServe has acquired an exclusive license of this technology and will perform a clinical phase I/II study for patients with chronic cardiomyopathy. The technology of CellServe is completely distinct from all competitors, using specialized stromal heart cells and not stem cells.
CellServe has an experienced management in cell-based therapies area to develop and market ATMP products. It will apply for a so-called hospital exemption regulation, a limited preliminary approval, for early market introduction directly after the clinical study.
Commercial potential: Worldwide 22 Mio people suffer from chronic cardiac insufficiency.
In Phase 1 a business plan for the CardAP cell product will be generated including financial calculations and the preparations for the clinical study will be finalised.
Achievements Phase 2: • Phase I/II clinical trial • Approval for Hospital Exemption for ATMPs • Preparation of a multicenter clinical trial • Fulfilment of all regulatory requirements to perform a phase III clinical study • Equity financing
Researchers at the Charité - University Medicine, have identified unique cardiac-specific stromal cells (CardAP cells) with strong efficacy in cardiac stress models. CardAP cells are specialized heart-derived cells with key advantages in safety and efficacy.
CardAP cells fulfil all criteria for cardiac cell therapy and cell product manufacturing has been transferred to GMP facilities. CellServe, a Charité spin off, will develop the CardAP cells for therapy of patients suffering from severe life-threatening cardiomyopathy.
CellServe has acquired an exclusive license of this technology and will perform a clinical phase I/II study for patients with chronic cardiomyopathy. The technology of CellServe is completely distinct from all competitors, using specialized stromal heart cells and not stem cells.
CellServe has an experienced management in cell-based therapies area to develop and market ATMP products. It will apply for a so-called hospital exemption regulation, a limited preliminary approval, for early market introduction directly after the clinical study.
Commercial potential: Worldwide 22 Mio people suffer from chronic cardiac insufficiency.
In Phase 1 a business plan for the CardAP cell product will be generated including financial calculations and the preparations for the clinical study will be finalised.
Achievements Phase 2: • Phase I/II clinical trial • Approval for Hospital Exemption for ATMPs • Preparation of a multicenter clinical trial • Fulfilment of all regulatory requirements to perform a phase III clinical study • Equity financing
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/735261 |
| Start date: | 01-07-2016 |
| End date: | 31-12-2016 |
| Total budget - Public funding: | 71 429,00 Euro - 50 000,00 Euro |
Cordis data
Original description
Chronic heart failure is a life-threatening disease usually without cure and a leading cause of morbidity and mortality. In Germany 45 000 patients (projected to EU: about 140 000) die every year from progressive chronic cardiac insufficiency. There is no curative therapeutic solution, except very rare donor hearts and artificial hearts as bridge devices.Researchers at the Charité - University Medicine, have identified unique cardiac-specific stromal cells (CardAP cells) with strong efficacy in cardiac stress models. CardAP cells are specialized heart-derived cells with key advantages in safety and efficacy.
CardAP cells fulfil all criteria for cardiac cell therapy and cell product manufacturing has been transferred to GMP facilities. CellServe, a Charité spin off, will develop the CardAP cells for therapy of patients suffering from severe life-threatening cardiomyopathy.
CellServe has acquired an exclusive license of this technology and will perform a clinical phase I/II study for patients with chronic cardiomyopathy. The technology of CellServe is completely distinct from all competitors, using specialized stromal heart cells and not stem cells.
CellServe has an experienced management in cell-based therapies area to develop and market ATMP products. It will apply for a so-called hospital exemption regulation, a limited preliminary approval, for early market introduction directly after the clinical study.
Commercial potential: Worldwide 22 Mio people suffer from chronic cardiac insufficiency.
In Phase 1 a business plan for the CardAP cell product will be generated including financial calculations and the preparations for the clinical study will be finalised.
Achievements Phase 2: • Phase I/II clinical trial • Approval for Hospital Exemption for ATMPs • Preparation of a multicenter clinical trial • Fulfilment of all regulatory requirements to perform a phase III clinical study • Equity financing
Status
CLOSEDCall topic
SMEInst-05-2016-2017Update Date
26-10-2022
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