PRP + tSVF for Premature Ovarian Failure

(OVAR-REJUV Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Black Tie Medical, Inc.

Must not be taking: Anticoagulants, Hormonal treatments

Disqualifiers: Genetic ovarian failure, Cancer, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve ovarian function in women experiencing premature ovarian failure, menopause, or perimenopause by testing injections directly into the ovaries. It compares the effectiveness of Platelet Rich Plasma (PRP) alone versus PRP combined with Stromal Vascular Fraction (tSVF), a special type of cell tissue derived from the patient's own fat tissue. Women who have experienced symptoms or hormone issues for at least six months, have not used hormone treatments for three months, and have at least one ovary may be eligible to participate. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

Yes, you will need to stop taking Hormonal Replacement Therapy, Botanotherapy, and Danazol at least 3 months before the study and avoid them for 12 months after the intervention. You also cannot be on anticoagulants or certain other medications during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments using Platelet Rich Plasma (PRP) are generally safe. Studies have used PRP without major issues to help restore ovarian function in women whose ovaries stop working before age 40 or are affected by chemotherapy or aging. No significant side effects have been reported with PRP injections in these cases.

Research has examined the combination of Stromal Vascular Fraction (tSVF) with PRP for rejuvenating ovaries. While the combination with tSVF is still under study, each component has shown safety on its own. Cells from fat tissue, like those in tSVF, have been used for other conditions with few side effects.

Using tSVF enriched with cellular stromal vascular fraction (cSVF) along with PRP is a newer approach. The safety of this treatment is still being studied, but the individual components have been tested separately without major safety concerns.

Since this trial is in the early stages, the main goal is to assess safety. More research is needed to confirm the safety of these combinations, but early studies on the individual components are encouraging. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for premature ovarian failure because they explore innovative ways to potentially rejuvenate ovarian function. Unlike traditional hormone replacement therapies, which mainly supplement hormones, these experimental treatments use Platelet Rich Plasma (PRP) and stromal vascular fraction (SVF) derived from the patient's own body. One unique feature is the use of emulsified tSVF and PRP, which combines regenerative components from adipose tissue with PRP to enhance tissue repair and function. Furthermore, one arm of the treatment enriches this blend with cSVF, adding a concentrated mix of cells that might boost the ovaries' regenerative capacity. This approach is cutting-edge because it leverages the body's natural healing processes, potentially offering a more personalized and regenerative alternative to existing treatments.

What evidence suggests that this trial's treatments could be effective for Premature Ovarian Failure?

Research shows that Platelet Rich Plasma (PRP), which participants in this trial may receive, can improve ovarian function in women with Premature Ovarian Failure. Studies have found that PRP therapy boosts markers of ovarian health and increases pregnancy chances. In this trial, some participants will receive PRP combined with emulsified Stromal Vascular Fraction (tSVF), which research has shown to enhance ovarian function by aiding tissue repair. Another treatment arm includes adding Cellular Stromal Vascular Fraction (cSVF) to the PRP and tSVF mix, which is under study for its potential to further increase these benefits. Early findings suggest these treatments might reactivate the ovaries and ease early menopause symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Women over 35 with Premature Ovarian Failure, Perimenopause, or hormone imbalance who've had symptoms for at least 6 months. Participants must not have used Hormonal Replacement Therapy or certain other treatments for 3 months and agree to avoid them for a year post-study. They should have at least one ovary and no history of ovarian cancer, untreated endocrine disorders, BMI >30 kg/m2, systemic autoimmune diseases, or mental health issues that would affect participation.

Inclusion Criteria

I stopped taking Hormonal Replacement Therapy over 3 months ago.

I have not taken Botanotherapy or Danazol for the last 3 months.

I agree to follow the study rules and not use hormone therapy or certain herbal treatments for a year after the study.

Exclusion Criteria

I have been diagnosed with cancer or had active cancer in the last 2 years.

I have a history of endometriosis.

I have an untreated hormone-related condition like thyroid issues or diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-ovarian injections of PRP, tSVF, or cSVF to improve ovarian function

1 day

1 visit (in-person)

Follow-up

Participants are monitored for hormonal response, ovarian morphology, bone density, and quality of life improvements

18 months

Regular visits every 3 months

Long-term Monitoring

Continued monitoring of bone density and body composition changes

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Cellular Isolation cSVF
• Endovaginal Ultrasound
• lipoaspiration harvest tSVF
• Platelet Rich Plasma

Trial Overview

The trial is testing the effectiveness of Platelet Rich Plasma (PRP) alone versus PRP combined with Stromal Vascular Fraction (tSVF/cSVF) in reactivating ovarian function. Women will receive imaging-guided intra-ovarian injections to compare how well these treatments work and how long their effects last.

How Is the Trial Designed?

Group I: ARM 4 Intra-ovarian guided placement Experimental Treatment 1 Intervention

Specifically designed 23 gauge modified oocyte harvester needle for ultrasound guided placement

Group II: ARM 3 emulsified tSVF and PRP, enriched with cSVF Experimental Treatment 6 Interventions

Blood draw, processing of PRP, white blood cell poor, high platelet multiple \>/= 4, e.g. Emcyte PRP tSVF preparation: Lipoaspiration utilizing closed microcannula harvesting of small volume (Tulip tumescent fluid infiltrator and Tulip Harvester). Decanting of free lipid. Emulsification of adipose tissue (Tulip Nanofat device). cSVF preparation: lipoaspiration as above. Isolation and Concentration of cellular stromal vascular fraction (cSVF) using a Healeon Medical CentriCyte 1000 centrifuge, incubator and shaker plate with sterile Liberase enzyme (Roche Medical) per manufacturer protocol. Quantification of viable nucleated cell count with flow cytometry. Addition of pellet of viable nucleated cells to tSVF. Blending of tSVF/cSVF emulsion with PRP at a 3:1 ratio. Endovaginal ultrasound guided intra-ovarian placement into ovary, preferably both if accessible. Intervention:

Group III: ARM 2 emulsified tSVF and PRP Experimental Treatment 5 Interventions

Blood draw, processing of PRP, white blood cell poor, high platelet multiple \>/= 4, e.g. Emcyte PRP Lipoaspiration utilizing closed microcannula harvesting of small volume (Tulip tumescent fluid infiltrator and Tulip Harvester). Decanting of free lipid. Emulsification of adipose tissue into tSVF (Tulip Nanofat device). Blending of Nanofat with PRP at a 3:1 ratio. Endovaginal ultrasound guided intra-ovarian placement into ovary, preferably both if accessible.

Group IV: ARM 1 Platelet Rich Plasma Experimental Treatment 3 Interventions

Blood draw, processing of PRP, white blood cell poor, high platelet multiple \>/= 4, e.g. (Emcyte II Pure PRP) Endovaginal ultrasound guided intra-ovarian placement into ovarian parenchyma, preferably both if accessible.

Who Is Running the Clinical Trial?

Black Tie Medical, Inc.

Lead Sponsor

Trials

2

Recruited

110+

Published Research Related to This Trial

Intraovarian injection of platelet rich plasma (PRP) shows promise in improving ovarian reserve markers and increasing oocyte and embryo yields in patients with poor ovarian response (POR) and primary ovarian insufficiency (POI), as indicated by several case series and one prospective trial.

Patients who previously failed treatment have reported multiple live births after receiving PRP injections, suggesting that this novel treatment could enhance fertility outcomes for those with poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of intraovarian injection of autologous platelet rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. Herlihy, NS., Seli, E.[2022]

Intra-ovarian injection of platelet-rich plasma (PRP) significantly increased anti-Müllerian hormone (AMH) levels in 22 women with poor ovarian reserve, suggesting a potential improvement in fertility.

While AMH levels rose after PRP treatment, there were no significant changes in antral follicle counts (AFC), indicating that while PRP may enhance ovarian function, it does not necessarily increase the number of visible follicles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-ovarian infusion of autologous platelet-rich plasma in women with poor ovarian reserve: A before and after study. Hosseinisadat, R., Farsi Nejad, A., Mohammadi, F.[2022]

In a study involving 28 female rats, platelet-rich plasma (PRP) was found to significantly protect ovarian function and improve oocyte count against damage caused by cyclophosphamide (CYC), a drug known to adversely affect fertility.

The results showed that rats treated with CYC plus PRP had a higher number of fertilized oocytes and better quality embryos compared to those treated with CYC alone, indicating that PRP enhances the effectiveness of in vitro fertilization procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective Effects of Platelet-rich plasma for in vitro Fertilization of Rats with Ovarian Failure Induced by Cyclophosphamide. Budak, Ö., Bostancı, MS., Toprak, V., et al.[2023]

Platelet-rich plasma (PRP) therapy may improve ovarian function and increase pregnancy chances in women with very low ovarian reserve and premature ovarian insufficiency, based on a review of 25 studies and 2 abstracts.

Despite some skepticism about PRP's role in fertility treatments, its low-risk profile and potential benefits warrant further investigation through larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. Seckin, S., Ramadan, H., Mouanness, M., et al.[2023]

Intraovarian injection of platelet-rich plasma (PRP) significantly improved oocyte count and quality in women with diminished ovarian reserve, with a 300% increase in oocytes for pregnant patients and a 125% increase for nonpregnant patients after treatment.

The study, which analyzed 60 out of 120 cases over a period from 2015 to 2020, found that PRP treatment also led to a significant increase in endometrial thickness and a decrease in follicle-stimulating hormone (FSH) levels, suggesting a positive impact on ovarian function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Platelet-Rich Plasma Treatment Increase In Vitro Fertilization (IVF) Success in the Infertile Population? Safarova, S., Cevher Akdulum, MF., Guler, I., et al.[2023]

Citations

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Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & ...

The study will compare the effectiveness of autologous Platelet Rich Plasma alone versus Stromal Vascular Fraction (tSVF and/or cellular stromal vascular ...

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Research trends on platelet-rich plasma in improving ...

Platelet-rich plasma (PRP) has attracted attention due to its potential to restore or enhance ovarian function. However, resources for evaluating the ...

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withpower.com

withpower.com/trial/phase-1-endocrine-system-diseases-5-2020-37d39

PRP + tSVF for Premature Ovarian Failure

This healing substance has been used in various medical fields to promote tissue regeneration and has shown promising results in improving ovarian function.

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This case series evaluates the effects of intraovarian PRP therapy on ovarian reserve markers and pregnancy outcomes in two women diagnosed with ...

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PRP treatment resulted in a statistically significant improvement in the main fertility parameters of diminished ovarian reserve women.

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The trial will explore the therapeutic effects of adipose tissue-derived stromal vascular fraction in patients with premature ovarian ...

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Mesenchymal stem cells and platelet rich plasma in the ...

Moreover, PRP has been found to have a protective effect against follicular atresia and death in rats with POF [45]. Primary ovarian failure is ...