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| Name | Class |
|---|---|
| BTI Biotechnology Institute S.L | UNKNOWN |
| Fundación IVI | OTHER |
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The samples used in PRGF treatments owe their effectiveness to the handling, concentration, and preservation of their components, which explains why samples obtained with different platelet-rich plasma preparation systems may vary. At IVIRMA Group, we employ the closed system PRGF-Endoret to process these samples for StemCell Regenera samples obtained after mobilizing stem cells with granulocyte colony-stimulating factor stimulators. According to current regulations, PRP samples are considered medicinal products by AEMPS, requiring knowledge of the composition of processed samples to be administered to the patient. The study and quantification of samples used in StemCell Regenera treatments aim to understand how stem cell mobilization performed through this technique influences the characteristics of PRGF-Endoret. In this context, the present project aims to systematically analyse the proteomic profile of PRP/PRGF before and after haematopoietic stem cell mobilisation in poor-responder patients, and to evaluate its biological impact in vitro using human ovarian cell models. This approach will enable the identification of key factors involved in ovarian activation and regeneration, thereby providing a mechanistic basis for optimising regenerative therapies applied in clinical reproductive medicine. Furthermore, it will contribute scientifically relevant insights to the field of research and to patients themselves.
The study design is based on a comparative analysis of the biological and proteomic profiles of platelet-rich plasma enriched with platelet-derived growth factors (PRP/PRGF) processed using the PRGF Endoret® kit, comparing samples obtained before (PRE) and after (POST) stem cell mobilization. The aim is to define the changes induced by the paracrine effect of bone marrow-derived stem cells (CD34⁺) mobilized into peripheral blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poor responders undergoing ovarian reactivation StemCell Regenera | Women who present a profile of poor responders meaning they have a poor response towards the ovarian stimulation treatment, yielding a low number of oocytes after oocyte retrieval and moreover want to undergo the ovarian reactivation treatment StemCell Regenera. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma + BMDSCs mobilization | Combination Product | This intervention entails, in addition to routine platelet-rich plasma (PRP) isolation, prior mobilization of bone marrow derived stem cells into the peripheral blood using filgrastim, a granulocyte colony-stimulating factor. Consequently, the patient benefits both from the stem cells and their paracrine effects on the ovaries, as well as from the direct effects of intraovarian PRP instillation. Overall, this approach provides multiple benefits derived from two distinct biological sources. |
| Measure | Description | Time Frame |
|---|---|---|
| Biological and proteomic characterisation of the platelet rich plasma | Proteomic and biological characterisation of the platelet rich plasma before and after the peripheral blood mobilization of bone marrow derived stem cells in women with poor ovarian response who undergo the ovarian reactivation treatment StemCell Regenera | From enrollment to the end of treatment (4 day treatment) at day 5 |
| In vitro functional studies with human ovarian cells | In vitro evaluation of the functional effect of PRP both before and after the stem cell mobilization on peripheral blood over human derived ovarian cells, analysing viability and proliferation parameters | From enrollment to the end of treatment (4 day treatment) at day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from IVI Alicante who decide to undergo the ovarian reactivation treatment "StemCell Regenera" at the clinic for improving ovarian function
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Muñoz Cantero, MD | Contact | +34 966012490 | Manuel.Munoz@ivirma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVIRMA Alicante | Alicante | Alicante | 03015 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
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| 27571179 |
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