PRP + tSVF for Premature Ovarian Failure
(OVAR-REJUV Trial)
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intra-ovarian injections of PRP, tSVF, or cSVF to improve ovarian function
Follow-up
Participants are monitored for hormonal response, ovarian morphology, bone density, and quality of life improvements
Long-term Monitoring
Continued monitoring of bone density and body composition changes
What Are the Treatments Tested in This Trial?
Interventions
- Cellular Isolation cSVF
- Endovaginal Ultrasound
- lipoaspiration harvest tSVF
- Platelet Rich Plasma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Black Tie Medical, Inc.
Lead Sponsor