PRP + tSVF for Premature Ovarian Failure

(OVAR-REJUV Trial)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Black Tie Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests injections of a healing mixture into the ovaries to help women with early menopause or ovarian failure. The mixture can be just a healing substance or combined with cells from their own fat. The goal is to improve ovarian function and hormone levels. This healing substance has been used in various medical fields to promote tissue regeneration and has shown promising results in improving ovarian function.

Eligibility Criteria

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.

Treatment Details

Interventions

• Cellular Isolation cSVF (Cell Therapy)
• Endovaginal Ultrasound (Procedure)
• lipoaspiration harvest tSVF (Cell Therapy)
• Platelet Rich Plasma (Biological)

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.

Participant Groups

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+