Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT05594433
Brief Summary:
Donation of whole blood by healthy volunteers after mobilisation by haematopoietic growth factor (rhu-G-CSF = Granocyte) for biological validation of a cell expansion automaton allowing the simultaneous production of several cell grafts for therapeutic use in the cardiac field - 2nd STAGE
Detailed Description:
The rationale for the MHS002 study is based on the expansion results obtained with the first version of the machine (MHS001):
* Average expansion rate of about 20-fold of CD34+ stem cells observed in a reproducible way on the Mulhouse and Créteil sites,
* No significant difference in phenotypic, immunological or morphological characteristics between the "naive" cells (not multiplied) and the cells after multiplication, nor any chromosomal alteration or hyperploidy: the expansion process developed does not lead to any cellular modification,
* Variability in the number of stem cells obtained after multiplication between healthy volunteers.
Developing a second generation prototype capable of producing 15 grafts per month, it is necessary to proceed with its biological validation, in the same way as the first generation prototype (protocol MHS001) was validated, following the requirements of regulatory agencies. Furthermore, in view of these results, it appeared necessary to define the lower limit of the number of CD34+ stem cells composing the graft, below which the therapeutic efficacy will be reduced or nil. This second stage of the study will make it possible to validate a potency test, i.e. a test making it possible to define the composition and potential effectiveness of the graft before its reinjection.
Given the absence of serious adverse events following the administration of G-CSF in healthy volunteers and in the context of the continued development of the second version of the automaton, validations similar to the first protocol are still necessary. Blood donation from healthy volunteers following stem cell mobilisation by G-CSF administration will allow validation of the second version.
Study:
NCT05594433
Study Brief:
Protocol Section:
NCT05594433