Poor Ovarian ResponseNCT07376460
Proteomic and Biological Characterisation of Plasma for the Study of Changes Following Ovarian Reactivation Treatment
An observational study of Poor Ovarian Response and Ovarian Reactivation, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Poor Ovarian Response, Ovarian Reactivation
- What is being tested?
- Platelet Rich Plasma + BMDSCs mobilization
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients from IVI Alicante who decide to undergo the ovarian reactivation treatment "StemCell Regenera" at the clinic for improving ovarian function
Who may be able to join
- Patients aged between 18 and 43.
- 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.
Who cannot join
- Patients over the age of 43.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
IVIRMA Alicante
Alicante, Alicante, 03015
Manuel Muñoz Cantero, MD, +34 966 012 490, manuel.munoz@ivirma.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Poor Ovarian Response, Ovarian Reactivation
- Being tested
- Platelet Rich Plasma + BMDSCs mobilization
- Keywords
- Poor ovarian response, ovarian reactivation, StemCell Regenera, ovarian rejuvenation therapy, ovarian failure, Stem cell mobilization, PRP, PRGF, Bone Marrow Derived Stem Cells (BMDSC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich Plasma + BMDSCs mobilizationCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Platelet Rich Plasma + BMDSCs mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of treatment (4 day treatment) at day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start6 Mar 2026
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Poor Ovarian ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI Alicante
- Sponsor type
- University, hospital or other
- Collaborators
- BTI Biotechnology Institute S.L, Fundación IVI
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376460
- Sponsor's protocol ID
- 2510-ALC-124-MM
- Status last verified
- Nov 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sfakianoudis K, Simopoulou M, Grigoriadis S, Pantou A, Tsioulou P, Maziotis E, Rapani A, Giannelou P, Nitsos N, Kokkali G, Koutsilieris M, Pantos K. Reactivating Ovarian Function through Autologous Platelet-Rich Plasma Intraovarian Infusion: Pilot Data on Premature Ovarian Insufficiency, Perimenopausal, Menopausal, and Poor Responder Women. J Clin Med. 2020 Jun 10;9(6):1809. doi: 10.3390/jcm9061809.
PubMed 32532000Zhai J, Yao G, Dong F, Bu Z, Cheng Y, Sato Y, Hu L, Zhang Y, Wang J, Dai S, Li J, Sun J, Hsueh AJ, Kawamura K, Sun Y. In Vitro Activation of Follicles and Fresh Tissue Auto-transplantation in Primary Ovarian Insufficiency Patients. J Clin Endocrinol Metab. 2016 Nov;101(11):4405-4412. doi: 10.1210/jc.2016-1589. Epub 2016 Aug 29.
PubMed 27571179Zeng X, Du L, Yang H, Wang F. Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with poor ovarian response: protocol for a multicentre, randomised, controlled trial. BMJ Open. 2023 Dec 30;13(12):e074135. doi: 10.1136/bmjopen-2023-074135.
PubMed 38159964Yuan L, Huang W, Bi Y, Chen S, Wang X, Li T, Wei P, Du J, Zhao L, Liu B, Yang Y. G-CSF-mobilized peripheral blood mononuclear cells combined with platelet-rich plasma restored the ovarian function of aged rats. J Reprod Immunol. 2023 Aug;158:103953. doi: 10.1016/j.jri.2023.103953. Epub 2023 May 16.
PubMed 37209460Tandulwadkar S, Karthick MS. Combined Use of Autologous Bone Marrow-derived Stem Cells and Platelet-rich Plasma for Ovarian Rejuvenation in Poor Responders. J Hum Reprod Sci. 2020 Jul-Sep;13(3):184-190. doi: 10.4103/jhrs.JHRS_130_19. Epub 2020 Oct 27.
PubMed 33311903Sills ES, Wood SH. Autologous activated platelet-rich plasma injection into adult human ovary tissue: molecular mechanism, analysis, and discussion of reproductive response. Biosci Rep. 2019 Jun 4;39(6):BSR20190805. doi: 10.1042/BSR20190805. Print 2019 Jun 28.
PubMed 31092698Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.
PubMed 35175511Santamaria A, Ballester A, Munoz M. Enhancing oocyte activation in women with ovarian failure: clinical outcomes of the Stem Cell Regenera study using G-CSF mobilization of peripheral blood stem cells and intraovarian injection of stem cell factor-enriched platelet rich plasma in real-world-practice. Aging (Albany NY). 2025 Jun 27;17(6):1571-1580. doi: 10.18632/aging.206274. Epub 2025 Jun 27.
PubMed 40587267Roberts LM, Herlihy N, Reig A, Titus S, Garcia-Milian R, Knight J, Yildirim RM, Margolis CK, Cakiroglu Y, Tiras B, Whitehead CV, Werner MD, Seli E. Transcriptomic landscape of cumulus cells from patients <38 years old with a history of poor ovarian response (POR) treated with platelet-rich plasma (PRP). Aging (Albany NY). 2025 Feb 18;17(2):431-447. doi: 10.18632/aging.206202. Epub 2025 Feb 18.
PubMed 39976580Reig A, Herraiz S, Pellicer A, Seli E. Emerging follicular activation strategies to treat women with poor ovarian response and primary ovarian insufficiency. Curr Opin Obstet Gynecol. 2021 Jun 1;33(3):241-248. doi: 10.1097/GCO.0000000000000703.
PubMed 33896920Polonio AM, Garcia-Velasco JA, Herraiz S. Stem Cell Paracrine Signaling for Treatment of Premature Ovarian Insufficiency. Front Endocrinol (Lausanne). 2021 Feb 24;11:626322. doi: 10.3389/fendo.2020.626322. eCollection 2020.
PubMed 33716956Pellicer N, Cozzolino M, Diaz-Garcia C, Galliano D, Cobo A, Pellicer A, Herraiz S. Ovarian rescue in women with premature ovarian insufficiency: facts and fiction. Reprod Biomed Online. 2023 Mar;46(3):543-565. doi: 10.1016/j.rbmo.2022.12.011. Epub 2022 Dec 20.
PubMed 36710157Orive G, Anitua E. Platelet-rich therapies as an emerging platform for regenerative medicine. Expert Opin Biol Ther. 2021 Dec;21(12):1603-1608. doi: 10.1080/14712598.2021.1936495. Epub 2021 Jun 7.
PubMed 34043484Nagy B, Kovacs K, Sulyok E, Varnagy A, Bodis J. Thrombocytes and Platelet-Rich Plasma as Modulators of Reproduction and Fertility. Int J Mol Sci. 2023 Dec 11;24(24):17336. doi: 10.3390/ijms242417336.
PubMed 38139165Molinaro P, Ballester A, Garcia-Velasco JA, Munoz M, Herraiz S. Impact of bilateral intraovarian platelet-rich plasma in women with poor ovarian response or primary ovarian insufficiency: a retrospective study. Fertil Steril. 2025 Sep;124(3):496-505. doi: 10.1016/j.fertnstert.2025.05.143. Epub 2025 May 14.
PubMed 40379042
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07376460
- Acronym / sponsor ID
- 2510-ALC-124-MM
- Conditions
- Poor Ovarian Response, Ovarian Reactivation
- Keywords
- Poor ovarian response, ovarian reactivation, StemCell Regenera, ovarian rejuvenation therapy, ovarian failure, Stem cell mobilization, PRP, PRGF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI AlicanteUniversity, hospital or other
- Collaborators
- BTI Biotechnology Institute S.L, Fundación IVI
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor responders undergoing ovarian reactivation StemCell Regenera | – | Combination Product: Platelet Rich Plasma + BMDSCs mobilizationWomen 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. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients from IVI Alicante who decide to undergo the ovarian reactivation treatment "StemCell Regenera" at the clinic for improving ovarian function
Key inclusion criteria (4 listed)
- Patients aged between 18 and 43.
- 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.
Key exclusion criteria (5 listed)
- Patients over the age of 43.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet Rich Plasma + BMDSCs mobilizationThis 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. | Combination product | Poor responders undergoing ovarian reactivation StemCell Regenera |
Primary outcome
Biological and proteomic characterisation of the platelet rich plasma
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 32532000Sfakianoudis K, Simopoulou M, Grigoriadis S, Pantou A, Tsioulou P, Maziotis E, Rapani A, Giannelou P, Nitsos N, Kokkali G, Koutsilieris M, Pantos K. Reactivating Ovarian Function through Autologous Platelet-Rich Plasma Intraovarian Infusion: Pilot Data on Premature Ovarian Insufficiency, Perimenopausal, Menopausal, and Poor Responder Women. J Clin Med. 2020 Jun 10;9(6):1809. doi: 10.3390/jcm9061809.
- Background: PubMed 27571179Zhai J, Yao G, Dong F, Bu Z, Cheng Y, Sato Y, Hu L, Zhang Y, Wang J, Dai S, Li J, Sun J, Hsueh AJ, Kawamura K, Sun Y. In Vitro Activation of Follicles and Fresh Tissue Auto-transplantation in Primary Ovarian Insufficiency Patients. J Clin Endocrinol Metab. 2016 Nov;101(11):4405-4412. doi: 10.1210/jc.2016-1589. Epub 2016 Aug 29.
- Background: PubMed 38159964Zeng X, Du L, Yang H, Wang F. Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with poor ovarian response: protocol for a multicentre, randomised, controlled trial. BMJ Open. 2023 Dec 30;13(12):e074135. doi: 10.1136/bmjopen-2023-074135.
- Background: PubMed 37209460Yuan L, Huang W, Bi Y, Chen S, Wang X, Li T, Wei P, Du J, Zhao L, Liu B, Yang Y. G-CSF-mobilized peripheral blood mononuclear cells combined with platelet-rich plasma restored the ovarian function of aged rats. J Reprod Immunol. 2023 Aug;158:103953. doi: 10.1016/j.jri.2023.103953. Epub 2023 May 16.
- Background: PubMed 33311903Tandulwadkar S, Karthick MS. Combined Use of Autologous Bone Marrow-derived Stem Cells and Platelet-rich Plasma for Ovarian Rejuvenation in Poor Responders. J Hum Reprod Sci. 2020 Jul-Sep;13(3):184-190. doi: 10.4103/jhrs.JHRS_130_19. Epub 2020 Oct 27.
- Background: PubMed 31092698Sills ES, Wood SH. Autologous activated platelet-rich plasma injection into adult human ovary tissue: molecular mechanism, analysis, and discussion of reproductive response. Biosci Rep. 2019 Jun 4;39(6):BSR20190805. doi: 10.1042/BSR20190805. Print 2019 Jun 28.
- Background: PubMed 35175511Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.
- Background: PubMed 40587267Santamaria A, Ballester A, Munoz M. Enhancing oocyte activation in women with ovarian failure: clinical outcomes of the Stem Cell Regenera study using G-CSF mobilization of peripheral blood stem cells and intraovarian injection of stem cell factor-enriched platelet rich plasma in real-world-practice. Aging (Albany NY). 2025 Jun 27;17(6):1571-1580. doi: 10.18632/aging.206274. Epub 2025 Jun 27.
- Background: PubMed 39976580Roberts LM, Herlihy N, Reig A, Titus S, Garcia-Milian R, Knight J, Yildirim RM, Margolis CK, Cakiroglu Y, Tiras B, Whitehead CV, Werner MD, Seli E. Transcriptomic landscape of cumulus cells from patients <38 years old with a history of poor ovarian response (POR) treated with platelet-rich plasma (PRP). Aging (Albany NY). 2025 Feb 18;17(2):431-447. doi: 10.18632/aging.206202. Epub 2025 Feb 18.
- Background: PubMed 33896920Reig A, Herraiz S, Pellicer A, Seli E. Emerging follicular activation strategies to treat women with poor ovarian response and primary ovarian insufficiency. Curr Opin Obstet Gynecol. 2021 Jun 1;33(3):241-248. doi: 10.1097/GCO.0000000000000703.
- Background: PubMed 33716956Polonio AM, Garcia-Velasco JA, Herraiz S. Stem Cell Paracrine Signaling for Treatment of Premature Ovarian Insufficiency. Front Endocrinol (Lausanne). 2021 Feb 24;11:626322. doi: 10.3389/fendo.2020.626322. eCollection 2020.
- Background: PubMed 36710157Pellicer N, Cozzolino M, Diaz-Garcia C, Galliano D, Cobo A, Pellicer A, Herraiz S. Ovarian rescue in women with premature ovarian insufficiency: facts and fiction. Reprod Biomed Online. 2023 Mar;46(3):543-565. doi: 10.1016/j.rbmo.2022.12.011. Epub 2022 Dec 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Ovarian Response and Ovarian Reactivation, run by Instituto Valenciano de Infertilidad, IVI Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manuel Muñoz Cantero, MD (+34 966012490, Manuel.Munoz@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological and proteomic characterisation of the platelet rich plasma (time frame: From enrollment to the end of treatment (4 day treatment) at day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376460, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.