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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degenerative Disc Disease patients undergoing spine surgery | Collection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery. |
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| Subjects undergoing plastic surgery | Collection of adipose tissue that would be considered as waste material after surgery. |
| |
| Pregnant female subjects | Collection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of patient-derived biological samples | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 months |
| Development of an organotypic spine unit model |
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DDD patients:
Subjects for the isolation of adipose-derived MSCs:
Subjects for the isolation of placenta-derived MSCs:
All enrolled subjects:
- Presence of HIV, HBV, HCV or TP infection
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Galeazzi-Sant'Ambrogio | Recruiting | Milan | MI | 20157 | Italy |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
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Collection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery.
Collection of adipose tissue that would be considered as waste material after surgery.
Collection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth.
|
Determination of success or failure in the development of spine unit models for each enrolled patient from which cell isolation has been successful. |
| 30 months |
| IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione | Not yet recruiting | Palermo | 90127 | Italy |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |