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Cell Therapy

PRP + tSVF for Premature Ovarian Failure (OVAR-REJUV Trial)

Phase 1

Waitlist Available

Research Sponsored by Black Tie Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to comply with study requirements, including avoiding HRT, Botanotherapy, Danazol for at least 12 months post intervention.

Presence of at least one ovary

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months, 6 months, 12 months, 18 months

Awards & highlights

OVAR-REJUV Trial Summary

This trial is testing whether injecting platelet-rich plasma and stromal vascular fraction into the ovaries can improve ovarian function in women with premature ovarian failure, menopausal symptoms, and/or early postmenopausal symptoms.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort from lipoaspiration (fat removal), injection site reactions like pain or bruising from PRP and tSVF/cSVF injections, bleeding due to needle insertion during ultrasound guidance, and possible pelvic adhesions.

OVAR-REJUV Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have at least one ovary.

OVAR-REJUV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months, 12 months, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 months, 6 months, 12 months, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months, 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient Safety For Procedure

Secondary outcome measures

Bone Density and Body Composition

Hormonal Response

Menstrual Resumption

+1 more

Other outcome measures

Health Related Quality of Life

OVAR-REJUV Trial Design

4Treatment groups

Experimental Treatment

Group I: ARM 4 Intra-ovarian guided placementExperimental Treatment1 Intervention

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

Group II: ARM 3 emulsified tSVF and PRP, enriched with cSVFExperimental Treatment6 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 PRPExperimental Treatment5 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 PlasmaExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet Rich Plasma

2016

Completed Phase 4

~1100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Black Tie Medical, Inc.Lead Sponsor

1 Previous Clinical Trials

10 Total Patients Enrolled

Media Library

Cellular Isolation cSVF (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04444245 — Phase 1

Premature Ovarian Failure Research Study Groups: ARM 2 emulsified tSVF and PRP, ARM 3 emulsified tSVF and PRP, enriched with cSVF, ARM 4 Intra-ovarian guided placement, ARM 1 Platelet Rich Plasma

Premature Ovarian Failure Clinical Trial 2023: Cellular Isolation cSVF Highlights & Side Effects. Trial Name: NCT04444245 — Phase 1

Cellular Isolation cSVF (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04444245 — Phase 1

Premature Ovarian Failure Patient Testimony for trial: Trial Name: NCT04444245 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include participants of eighteen years or older?

"This research requires participants aged 35 to 60. There are 21 clinical trials for minors and 24 studies open to seniors."

Answered by AI

What potential risks are associated with Platelet Rich Plasma treatments?

"Our team at Power has judged that the safety of Platelet Rich Plasma is a 1, as it is currently in Phase 1 trials and thus lacks substantial evidence regarding its efficacy and security."

Answered by AI

Who is eligible to partake in this research endeavor?

"The medical trial is searching for 100 individuals aged between 35 and 60 that suffer from ovarian failure. To qualify, potential participants must commit to the following criteria: adhering to study procedures; abstaining from HRT, Botanotherapy, and Danazol post-intervention for 12 months; having ceased using HRT at least 3 months prior to involvement; displaying signs of hormonal derangement over 6 consecutive months; being a woman older than 35 years old; reporting pregnancy without fail directly to research personnel involved in the project; agreeing with all other requirements stipulated by the trial protocol."

Answered by AI

Are recruitment efforts currently underway for this trial?

"Clinicaltrials.gov states that this research initiative is no longer searching for participants, having initiated the recruitment process on July 15th 2022 and last edited it on the 18th of that same month. Despite its closure, there are still 52 other investigations actively recruiting subjects."

Answered by AI

Who else is applying?

What state do they live in?

Vermont

New York

Other

Colorado

How old are they?

18 - 65

What site did they apply to?

Fanny Island Campus Medical Building

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I would like to try this to improve POF symptoms. I have been experiencing perimenopause symptoms, and I am not ready to give up on my fertility. If this can slow down the process, that's what I'm hoping for.

PatientReceived 2+ prior treatments

I have been diagnosed with primary ovarian insufficiency. I would like to try to improve my ovarian function so I don’t have to take hormone replacement forever. I would also like to ease all of my menopause symptoms.

PatientReceived 2+ prior treatments