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临床试验/NCT07376460
NCT07376460尚未招募不适用

Biological and Proteomic Characterisation of Platelet-rich Plasma (PRP) Before and After Mobilisation of Haematopoietic Stem Cells in Peripheral Blood From Women With Low Ovarian Response (Low Responders) and in Vitro Evaluation in Human Ovarian Cell Models

Instituto Valenciano de Infertilidad, IVI Alicante1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Biological and proteomic characterisation of the platelet rich plasma

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 43 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged between 18 and
  • Patients diagnosed with poor ovarian response (POR) or low ovarian reserve according to Bolonia criteria (ESHRE).
  • Patients who are indicated for a StemCell Regenera procedure with the use of granulocyte colony-stimulating factors (Filgrastim).
  • Patients who agree to participate and sign the informed consent form.

排除标准

  • Patients over the age of
  • Patients with only one ovary.
  • Patients with an autoimmune or haematological disorder.
  • Patients currently undergoing treatment with anticoagulant drugs.
  • Patients who are allergic to Filgrastim, the granulocyte colony-stimulating factor.

研究组 & 干预措施

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.

干预措施: Platelet Rich Plasma + BMDSCs mobilization (Combination Product)

结局指标

主要结局

Biological and proteomic characterisation of the platelet rich plasma

时间窗: From enrollment to the end of treatment (4 day treatment) at day 5

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

In vitro functional studies with human ovarian cells

时间窗: From enrollment to the end of treatment (4 day treatment) at day 5

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

次要结局

未报告次要终点

研究者

发起方
Instituto Valenciano de Infertilidad, IVI Alicante
申办方类型
Other
责任方
Sponsor

研究点 (1)

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