An observational study in Degenerative Disc Disease, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 2 sites in Italy. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc.
In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. Given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the DDD-related pathways and to screen promising treatments such as MSC-based therapies.
The primary aim of this study is to investigate the response of an inflamed organotypic spine unit model, intended as a 3D in vitro representation of an in vivo environment, to the treatment with mesenchymal stem cells (MSC)-derived secretome. In particular to investigate the ability of MSC-derived secretome to modulate genes found to be upregulated or downregulated by the inflammatory stimulation in the spine unit model and bring their expression back to a basal state.
Secondary aims of the study are:
464 studies on the registry are indexed under Intervertebral Disc Degeneration; 98 are open to participants now.
This study's planned enrollment of 20 is below the median of 120 across 166 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.
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Samples will be collected from Degenerative Disc Disease patients undergoing spine surgery, from patients subjected to surgeries that involve the removal of adipose tissue and from pregnant women within 6 hours from giving birth.
DDD patients:
Subjects for the isolation of adipose-derived MSCs:
Subjects for the isolation of placenta-derived MSCs:
All enrolled subjects:
Collection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery.
Other: Use of patient-derived biological samples
Collection of adipose tissue that would be considered as waste material after surgery.
Other: Use of patient-derived biological samples
Collection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth.
Other: Use of patient-derived biological samples
We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.
Efficacy of MSC-derived secretome
Changes in gene expression in response to the treatment of the spine unit model with MSC-derived secretome. If the MSC-derived secretome is effective, genes upregulated or downregulated by inflammatory stimulation are expected to go back to their basal levels when the inflamed model is treated with MSC-derived secretome.
Time frame: 30 months
Characterization of patient-specific degenerative features
Identification of circulating degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating with tissue degeneration.
Time frame: 30 months
Development of an organotypic spine unit model
Determination of success or failure in the development of spine unit models for each enrolled patient from which cell isolation has been successful.
Time frame: 30 months
Plan to share: No
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Intervertebral Disc Degeneration→
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio