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Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF

NCT04444245 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-07-19

No results posted yet for this study

Summary

Trial of imaging guided intra-ovarian injection to improve ovarian function in clinical settings of Premature Ovarian Failure, Perimenopausal and /or early postmenopausal symptomatology and related hormonal deficiencies. The study will compare the effectiveness of autologous Platelet Rich Plasma alone versus Stromal Vascular Fraction (tSVF and/or cellular stromal vascular fraction (cSVF) in combination with Platelet Rich Plasma as regards efficacy and duration of ovarian reactivation in women with acquired Premature Ovarian Failure, Menopausal, and Perimenopausal women.

Conditions

  • Ovarian Failure
  • Perimenopausal Disorder
  • Hormone Disturbance

Interventions

PROCEDURE

lipoaspiration harvest tSVF

Use of disposable, sterile microcannula lipoharvest to acquire tSVF

PROCEDURE

Platelet Rich Plasma

Standard venipuncture, concentration of PRP in FDA approved device (Emcyte II)

PROCEDURE

Endovaginal Ultrasound

Endovaginal Ultrasound guidance to intra-ovarian placement, bilaterally

DEVICE

Cellular Isolation cSVF

Digestion of tSVF with Liberase, isolation \& concentration of cSVF in Centricyte 1000

DRUG

Normal Saline (NS) .9% 10 mL Injection

10 cc Sterile Normal Saline for Injection

DEVICE

emulsification tSVF

Harvested tSVF emulsification with sterile, disposable Nanofat screen device

Sponsors & Collaborators

  • Black Tie Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2024-09-30
Completion
2025-08-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04444245 on ClinicalTrials.gov