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

• Status: Active, not recruiting
• Trial end date: 2023-08-15
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Black Tie Medical, Inc.; Healeon Medical Inc

Criteria

Inclusion Criteria:

• Symptomatology or hormonal derangement for at least 6 months

• Stopped Hormonal Replacement Therapy (HRT) for at least 3 months prior to intervention

• Stopped Botanotherapy / Danazol for 3 months

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

• Women over the age of 35

• Presence of at least one ovary

• Agree to report any pregnancy to the research staff immediately.

• Willing and able to comply with study requirements.

Exclusion Criteria:

• Current or previous Immune Globulin A (IgA) deficiency

• Current or previous premature ovarian failure due to a genetic origin, such as Turner's Syndrome or chromosomal abnormality

• Current or previous injuries or adhesions to the pelvis or ovaries

• Current and ongoing pregnancy

• Current and ongoing anticoagulant use

• Known bleeding diathesis

• Current and ongoing major Mental health disorder that precludes participation in the study

• Current and ongoing active substance abuse or dependence

• Prior or current ovarian malignancy, or known genetic mutation

• Current and ongoing chronic pelvic pain other than dyspareunia or vulval/vaginal integument disorders

• History of endometriosis

• Current diagnosis of cancer or active cancer within last 24 months

• Ovarian inaccessibility determined by endovaginal sonography

• Current or previous premature ovarian failure

• Active, untreated Endocrinologic disorders (uncompensated thyroid dysfunction, insulin dependant diabetes (type 1, type2)

• Body Mass Index (BMI) >30 kg/m2

• Systemic autoimmune disorder

• Know Polycystic Ovarian Syndrome

• Unwilling to terminate ovarian pharmaceuticals or exogenous hormone treatments 3 months prior to entering study, and to avoid exogenous hormones for duration of study