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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005717-40 | EudraCT Number |
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In the last years, platelet-rich plasma (PRP) has emerged as a promising alternative to treat endometrial pathologies affecting the endometrial lining. Different studies have tried this therapeutic approach in human patient, but results are not conclusive at all. Also, in the last years, different studies have suggested the umbilical cord blood has a stronger reservoir of growth factors and other pro-regenerative molecules than the adult peripheral blood. That is the reason why the present study aims to evaluate if using platelet-rich plasma obtained from umbilical cord blood is able to increase endometrial thickness and prepare the endometrium for an embryo transference. However, due to the novelty of this approach, the investigators have considered to include a 'proof of concept' group (women with premature ovarian insufficiency) to obtain a deeper understanding of the clinical value of this blood derivative.
Phase II clinical trial, designed as a pilot study, single-center and open-label, which aims to study the efficacy of platelet-rich plasma from umbilical cord after injection into a pathological endometrium (thin endometrium, Asherman's Syndrome, endometrial atrophy).
This treatment will be applied to patients with the aforementioned endometrial pathologies (group B), as well as to patients with premature ovarian failure (group A), which will serve to study its clinical value in greater detail. Plasma samples as well as endometrial biopsies will be analyzed to try to understand what molecular events are triggered in the endometrial tissue after the application of the treatment under study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Umbilical cord PRP donors | Other | Women who are going to give birth to a healthy live newborn at the Hospital Universitario y Politécnico La Fe. Donors will donate their umbilical cord blood to obtain the hUC-PRP. A total of 30±15 donors will be recruited. |
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| Group B- Asherman with PRP treatment and estrogen therapy | Experimental | Women with thin endometrium/endometrial atrophy and/or Asherman's syndrome with fertility problems and reproductive desires, desires that could be achieved by their participation in the present study. A total of 15 patients will be included; all of them will receive the investigational treatment as well as estrogen therapy. |
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| Group A1- POI with PRP treatment and estrogen therapy | Other | Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the investigational treatment as well as estrogen therapy. |
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| Group A2- POI with estrogen therapy | Other | Women with premature ovarian failure (POI). A total of 10 patients will be included. All of them will receive the estrogen therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of hUC-PRP by hysteroscopy | Procedure | PRP previously frozen at -80ºC (6±2 mL) will be defrozen after checking donor-receptor compatibility and viral safety study. PRP (4±2 mL) will be activated with 5% CaCl2 and immediately injected (4±2 mL) in the sub-endometrial wall via hysteroscopy. |
| Measure | Description | Time Frame |
|---|---|---|
| Study of endometrial regeneration and/or improvement in patients with endometrial pathologies (thin endometrium/Asherman's syndrome/endometrial atrophy) treated with platelet-rich plasma from the umbilical cord by endometrial thickeness. | Improvement will be studied in form of tissue thickening (mm), comparing endometrial thickness before and after PRP injection | An average of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proof-of-concept in POI patients by improvement endometrial thickeness. | Improvement will be studied in form of tissue thickening (mm), comparing endometrial thickness before and after PRP injection. | An average of 3 months |
| Gene and protein level evaluation of the endometrial biopsies collected. |
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UMBILICAL CORD DONORS
Donors of umbilical cord blood will be women (and their partners, if applicable) who give birth to a live newborn(s) in the Gynecology and Obstetrics service of HUP La Fe; the same umbilical cord collection criteria will be followed as standardized in HUP La Fe for the donation of this biological product.
GROUP A
Inclusion Criteria:
Exclusion Criteria:
GROUP B
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mónica Romeu Villaroya, MD., PhD. | Hospital La Fe | Principal Investigator |
| Irene Cervelló Alcaráz, PhD. | IVI Foundation/ IIS La Fe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital la Fe | Valencia | Valencia | 46026 | Spain |
All IPD that underlie results in a publication
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Recruitment period:
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| Group A3- POI without PRP treatment nor estrogen therapy | Other | Women with premature ovarian failure (POI). A total of 10 patients will be included. None of them will receive either the investigational treatment nor estrogen therapy. |
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| Oestraclin | Drug | Patients will receive estrogenic therapy, based on estradiol, for 10±2 days (oestraclin, topical cream, 5µg daily for 10±2 days). |
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| Umbilical cord blood collection | Procedure | The SCU will be collected using a blood collection bag containing anticoagulant. This step will be performed by the medical and nursing staff of the obstetrics service of the HUP La Fe. The blood collection bags will be the following, or similar: Cord Blood Collection Bags from MACOPHARMA; CPD Umbilical Cord Bag from GRIFOLS. |
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| Endometrial biopsy | Procedure | Biopsies will be taken by specialized medical personnel by aspiration with an intrauterine cannula (pipelle or cornier). Samples will be collected in 15 mL tubes (or in a larger capacity container if needed) containing PBS or RNA later until frozen at -80ºC, at the IVI Foundation facilities. Prior to freezing (in a 1.8-2 mL cryotube) the PBS will be removed and the sample cleaned in a Petri dish if needed. |
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Different molecular and histological assays will be performed with the biopsies from all the groups. |
| An average of 3 years |
| Study of the molecular composition of the different plasma fractions obtained from collected umbilical cord samples. | Different molecular assays will be performed with the blood samples obtained. | An average of 3 years |
| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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