What is the mechanism of action of this treatment?

The most common treatments for Premature Ovarian Failure (POF) include Autologous Platelet Rich Plasma (PRP) and Stromal Vascular Fraction (SVF) in combination with PRP. PRP contains growth factors that may promote tissue regeneration and improve ovarian function. SVF, which contains stem cells and other regenerative cells, may enhance the effects of PRP and further improve ovarian function. These treatments aim to reactivate ovarian function, which is crucial for POF patients as it may restore fertility and alleviate symptoms associated with hormonal deficiencies.

What side effects are associated with this type of intervention?

The most common side effects of treatments for Premature Ovarian Failure (POF) using Autologous Platelet Rich Plasma (PRP) and Stromal Vascular Fraction (SVF) in combination with PRP include minor and transient risks such as pain, bleeding, tenderness, swelling, and bruising at the injection site. There is also a potential risk of local infection and inflammation. These treatments are generally considered safe and aim to improve ovarian function with minimal adverse effects.

What prior FDA approvals exist?

There are no specific FDA approvals mentioned in the provided context for the treatment of Premature Ovarian Failure (POF) using Platelet Rich Plasma (PRP) or Stromal Vascular Fraction (SVF) in combination with PRP. The context discusses investigational approaches and ongoing trials evaluating the effectiveness of these treatments. PRP contains growth factors that may promote tissue regeneration and improve ovarian function, while SVF contains stem cells and other regenerative cells that may enhance the effects of PRP. However, these treatments are still under investigation and have not yet received FDA approval for POF.

What other types of research exist?

Promising novel alternatives to PRP and SVF for treating Premature Ovarian Failure include stem cell therapy and low-intensity shock therapy (LIST). Stem cell therapy, particularly using adipose-derived stem cells (ADSCs), has shown potential in regenerative medicine. LIST, which involves delivering low-intensity shocks to stimulate angiogenesis and improve tissue function, is another emerging technology. Both therapies are still under investigation but offer potential benefits for ovarian function improvement.

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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

Must not have

Current diagnosis of cancer or active cancer within last 24 months

History of endometriosis

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a history of endometriosis.

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

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I have ongoing pelvic pain not related to sexual activity or skin issues.

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I have had ovarian cancer or carry a known cancer-related genetic mutation.

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I have a systemic autoimmune disorder.

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I have experienced early menopause.

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My ovaries cannot be seen on a special ultrasound.

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I have had injuries or scarring in my pelvis or ovaries.

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I have a bleeding disorder.

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I am currently using blood thinners regularly.

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I have premature ovarian failure due to a genetic condition like Turner's Syndrome.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient Safety For Procedure

Secondary study objectives

Bone Density and Body Composition

Hormonal Response

Menstrual Resumption

+1 more

Other study objectives

Health Related Quality of Life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Premature Ovarian Failure (POF) include Autologous Platelet Rich Plasma (PRP) and Stromal Vascular Fraction (SVF) in combination with PRP. PRP contains growth factors that may promote tissue regeneration and improve ovarian function. SVF, which contains stem cells and other regenerative cells, may enhance the effects of PRP and further improve ovarian function. These treatments aim to reactivate ovarian function, which is crucial for POF patients as it may restore fertility and alleviate symptoms associated with hormonal deficiencies.