Ovarian Rejuvenation Using Platelet Rich Plasma (PRP) & Autologous Tissue Stromal Vascular Fraction (tSVF) and Cell Enriched tSVF (OVAR-REJUV)
Ovarian Failure, Perimenopausal Disorder, Hormone Disturbance
About this trial
This is an interventional treatment trial for Ovarian Failure
Eligibility 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
Sites / Locations
- Fanny Island Campus Medical Building
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
ARM 1 Platelet Rich Plasma
ARM 2 emulsified tSVF and PRP
ARM 3 emulsified tSVF and PRP, enriched with cSVF
ARM 4 Intra-ovarian guided placement
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.
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.
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:
Specifically designed 23 gauge modified oocyte harvester needle for ultrasound guided placement