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

NCT04444245 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: OVARIAN REJUV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Patient Safety For Procedure

  Reporting of all Adverse Events, Severe Adverse Events

  30 days

Secondary Outcomes (4)

• Menstrual Resumption

  baseline through 18 months

• Hormonal Response

  Baseline, 3 months, 6 months, 12 months, 18 months

• Ovarian Morphology

  Baseline, 6 month, 12 month, 18 month

• Bone Density and Body Composition

  Baseline, 12 and/or 18 months

Other Outcomes (1)

• Health Related Quality of Life

  Baseline, 6 months, 12 months

Study Arms (4)

ARM 1 Platelet Rich Plasma

EXPERIMENTAL

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.

Procedure: lipoaspiration harvest tSVF; Procedure: Platelet Rich Plasma; Procedure: Endovaginal Ultrasound

ARM 2 emulsified tSVF and PRP

EXPERIMENTAL

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.

Procedure: lipoaspiration harvest tSVF; Procedure: Platelet Rich Plasma; Procedure: Endovaginal Ultrasound; Drug: Normal Saline (NS) .9% 10 mL Injection; Device: emulsification tSVF

ARM 3 emulsified tSVF and PRP, enriched with cSVF

EXPERIMENTAL

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:

Procedure: lipoaspiration harvest tSVF; Procedure: Platelet Rich Plasma; Procedure: Endovaginal Ultrasound; Device: Cellular Isolation cSVF; Drug: Normal Saline (NS) .9% 10 mL Injection; Device: emulsification tSVF

ARM 4 Intra-ovarian guided placement

EXPERIMENTAL

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

Procedure: Endovaginal Ultrasound

Interventions

lipoaspiration harvest tSVF PROCEDURE

Use of disposable, sterile microcannula lipoharvest to acquire tSVF

ARM 1 Platelet Rich Plasma; ARM 2 emulsified tSVF and PRP; ARM 3 emulsified tSVF and PRP, enriched with cSVF

Platelet Rich Plasma PROCEDURE

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

ARM 1 Platelet Rich Plasma; ARM 2 emulsified tSVF and PRP; ARM 3 emulsified tSVF and PRP, enriched with cSVF

Endovaginal Ultrasound PROCEDURE

Endovaginal Ultrasound guidance to intra-ovarian placement, bilaterally

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

Cellular Isolation cSVF DEVICE

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

ARM 3 emulsified tSVF and PRP, enriched with cSVF

Normal Saline (NS) .9% 10 mL Injection DRUG

10 cc Sterile Normal Saline for Injection

ARM 2 emulsified tSVF and PRP; ARM 3 emulsified tSVF and PRP, enriched with cSVF

emulsification tSVF DEVICE

Harvested tSVF emulsification with sterile, disposable Nanofat screen device

ARM 2 emulsified tSVF and PRP; ARM 3 emulsified tSVF and PRP, enriched with cSVF

Eligibility Criteria

• Age: 35 Years - 60 Years
• Gender Eligibility Details: Ovaries must be present.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Black Tie Medical, Inc.: lead

Study Sites (1)

Fanny Island Campus Medical Building

Colchester, Vermont, 05446, United States

Location

Related Publications (64)

• He Y, Chen D, Yang L, Hou Q, Ma H, Xu X. The therapeutic potential of bone marrow mesenchymal stem cells in premature ovarian failure. Stem Cell Res Ther. 2018 Oct 4;9(1):263. doi: 10.1186/s13287-018-1008-9.

  PMID: 30286808 BACKGROUND

• Sills ES, Rickers NS, Li X, Palermo GD. First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 2018 Sep;34(9):756-760. doi: 10.1080/09513590.2018.1445219. Epub 2018 Feb 28.

  PMID: 29486615 BACKGROUND

• Bertone-Johnson ER, Manson JE, Purdue-Smithe AC, Steiner AZ, Eliassen AH, Hankinson SE, Rosner BA, Whitcomb BW. Anti-Mullerian hormone levels and incidence of early natural menopause in a prospective study. Hum Reprod. 2018 Jun 1;33(6):1175-1182. doi: 10.1093/humrep/dey077.

  PMID: 29659835 BACKGROUND

• Ji MX, Yu Q. Primary osteoporosis in postmenopausal women. Chronic Dis Transl Med. 2015 Mar 21;1(1):9-13. doi: 10.1016/j.cdtm.2015.02.006. eCollection 2015 Mar. No abstract available.

  PMID: 29062981 BACKGROUND

• Li J, Yu Q, Huang H, Deng W, Cao X, Adu-Frimpong M, Yu J, Xu X. Human chorionic plate-derived mesenchymal stem cells transplantation restores ovarian function in a chemotherapy-induced mouse model of premature ovarian failure. Stem Cell Res Ther. 2018 Apr 3;9(1):81. doi: 10.1186/s13287-018-0819-z.

  PMID: 29615109 BACKGROUND

• Liu M, Qiu Y, Xue Z, Wu R, Li J, Niu X, Yuan J, Wang Y, Wu Q. Small extracellular vesicles derived from embryonic stem cells restore ovarian function of premature ovarian failure through PI3K/AKT signaling pathway. Stem Cell Res Ther. 2020 Jan 3;11(1):3. doi: 10.1186/s13287-019-1508-2.

  PMID: 31900201 BACKGROUND

• Vermeulen M, Giudice MG, Del Vento F, Wyns C. Role of stem cells in fertility preservation: current insights. Stem Cells Cloning. 2019 Aug 5;12:27-48. doi: 10.2147/SCCAA.S178490. eCollection 2019.

  PMID: 31496751 BACKGROUND

• Zhang X, Niu J, Che T, Zhu Y, Zhang H, Qu J. Fertility preservation in BRCA mutation carriers-efficacy and safety issues: a review. Reprod Biol Endocrinol. 2020 Feb 18;18(1):11. doi: 10.1186/s12958-019-0561-0.

  PMID: 32070378 BACKGROUND

• Ling L, Feng X, Wei T, Wang Y, Wang Y, Wang Z, Tang D, Luo Y, Xiong Z. Human amnion-derived mesenchymal stem cell (hAD-MSC) transplantation improves ovarian function in rats with premature ovarian insufficiency (POI) at least partly through a paracrine mechanism. Stem Cell Res Ther. 2019 Jan 25;10(1):46. doi: 10.1186/s13287-019-1136-x.

  PMID: 30683144 BACKGROUND

• Su J, Ding L, Cheng J, Yang J, Li X, Yan G, Sun H, Dai J, Hu Y. Transplantation of adipose-derived stem cells combined with collagen scaffolds restores ovarian function in a rat model of premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):1075-86. doi: 10.1093/humrep/dew041. Epub 2016 Mar 9.

  PMID: 26965432 BACKGROUND

• Zhao YX, Chen SR, Su PP, Huang FH, Shi YC, Shi QY, Lin S. Using Mesenchymal Stem Cells to Treat Female Infertility: An Update on Female Reproductive Diseases. Stem Cells Int. 2019 Dec 6;2019:9071720. doi: 10.1155/2019/9071720. eCollection 2019.

  PMID: 31885630 BACKGROUND

• Liu R, Zhang X, Fan Z, Wang Y, Yao G, Wan X, Liu Z, Yang B, Yu L. Human amniotic mesenchymal stem cells improve the follicular microenvironment to recover ovarian function in premature ovarian failure mice. Stem Cell Res Ther. 2019 Oct 2;10(1):299. doi: 10.1186/s13287-019-1315-9.

  PMID: 31578152 BACKGROUND

• Yoon SY. Mesenchymal stem cells for restoration of ovarian function. Clin Exp Reprod Med. 2019 Mar;46(1):1-7. doi: 10.5653/cerm.2019.46.1.1. Epub 2019 Mar 1.

  PMID: 30827071 BACKGROUND

• Chen L, Guo S, Wei C, Li H, Wang H, Xu Y. Effect of stem cell transplantation of premature ovarian failure in animal models and patients: A meta-analysis and case report. Exp Ther Med. 2018 May;15(5):4105-4118. doi: 10.3892/etm.2018.5970. Epub 2018 Mar 20.

  PMID: 29755593 BACKGROUND

• Tabatabaei Qomi R, Sheykhhasan M. Adipose-derived stromal cell in regenerative medicine: A review. World J Stem Cells. 2017 Aug 26;9(8):107-117. doi: 10.4252/wjsc.v9.i8.107.

  PMID: 28928907 BACKGROUND

• Ding C, Li H, Wang Y, Wang F, Wu H, Chen R, Lv J, Wang W, Huang B. Different therapeutic effects of cells derived from human amniotic membrane on premature ovarian aging depend on distinct cellular biological characteristics. Stem Cell Res Ther. 2017 Jul 27;8(1):173. doi: 10.1186/s13287-017-0613-3.

  PMID: 28750654 BACKGROUND

• Li F, Zhou C, Xu L, Tao S, Zhao J, Gu Q. Effect of Stem Cell Therapy on Bone Mineral Density: A Meta-Analysis of Preclinical Studies in Animal Models of Osteoporosis. PLoS One. 2016 Feb 16;11(2):e0149400. doi: 10.1371/journal.pone.0149400. eCollection 2016.

  PMID: 26882451 BACKGROUND

• Bidet M, Bachelot A, Bissauge E, Golmard JL, Gricourt S, Dulon J, Coussieu C, Badachi Y, Touraine P. Resumption of ovarian function and pregnancies in 358 patients with premature ovarian failure. J Clin Endocrinol Metab. 2011 Dec;96(12):3864-72. doi: 10.1210/jc.2011-1038. Epub 2011 Oct 12.

  PMID: 21994953 BACKGROUND

• Cordts EB, Christofolini DM, Dos Santos AA, Bianco B, Barbosa CP. Genetic aspects of premature ovarian failure: a literature review. Arch Gynecol Obstet. 2011 Mar;283(3):635-43. doi: 10.1007/s00404-010-1815-4. Epub 2010 Dec 29.

  PMID: 21188402 BACKGROUND

• Miao Y, Wang P, Xie B, Yang M, Li S, Cui Z, Fan Y, Li M, Xiong B. BRCA2 deficiency is a potential driver for human primary ovarian insufficiency. Cell Death Dis. 2019 Jun 17;10(7):474. doi: 10.1038/s41419-019-1720-0.

  PMID: 31209201 BACKGROUND

• Hernandez-Angeles C, Castelo-Branco C. Early menopause: A hazard to a woman's health. Indian J Med Res. 2016 Apr;143(4):420-7. doi: 10.4103/0971-5916.184283.

  PMID: 27377497 BACKGROUND

• Guo Y, Sun J, Lai D. Role of microRNAs in premature ovarian insufficiency. Reprod Biol Endocrinol. 2017 May 12;15(1):38. doi: 10.1186/s12958-017-0256-3.

  PMID: 28499456 BACKGROUND

• Chen X, Wang Q, Li X, Wang Q, Xie J, Fu X. Heat shock pretreatment of mesenchymal stem cells for inhibiting the apoptosis of ovarian granulosa cells enhanced the repair effect on chemotherapy-induced premature ovarian failure. Stem Cell Res Ther. 2018 Sep 26;9(1):240. doi: 10.1186/s13287-018-0964-4.

  PMID: 30257708 BACKGROUND

• Vural B, Duruksu G, Vural F, Gorguc M, Karaoz E. Effects of VEGF + Mesenchymal Stem Cells and Platelet-Rich Plasma on Inbred Rat Ovarian Functions in Cyclophosphamide-Induced Premature Ovarian Insufficiency Model. Stem Cell Rev Rep. 2019 Aug;15(4):558-573. doi: 10.1007/s12015-019-09892-5.

  PMID: 31037585 BACKGROUND

• Liu C, Yin H, Jiang H, Du X, Wang C, Liu Y, Li Y, Yang Z. Extracellular Vesicles Derived from Mesenchymal Stem Cells Recover Fertility of Premature Ovarian Insufficiency Mice and the Effects on their Offspring. Cell Transplant. 2020 Jan-Dec;29:963689720923575. doi: 10.1177/0963689720923575.

  PMID: 32363925 BACKGROUND

• Ding C, Zou Q, Wang F, Wu H, Chen R, Lv J, Ling M, Sun J, Wang W, Li H, Huang B. Human amniotic mesenchymal stem cells improve ovarian function in natural aging through secreting hepatocyte growth factor and epidermal growth factor. Stem Cell Res Ther. 2018 Mar 9;9(1):55. doi: 10.1186/s13287-018-0781-9.

  PMID: 29523193 BACKGROUND

• Li J, Mao Q, He J, She H, Zhang Z, Yin C. Human umbilical cord mesenchymal stem cells improve the reserve function of perimenopausal ovary via a paracrine mechanism. Stem Cell Res Ther. 2017 Mar 9;8(1):55. doi: 10.1186/s13287-017-0514-5.

  PMID: 28279229 BACKGROUND

• Takehara Y, Yabuuchi A, Ezoe K, Kuroda T, Yamadera R, Sano C, Murata N, Aida T, Nakama K, Aono F, Aoyama N, Kato K, Kato O. The restorative effects of adipose-derived mesenchymal stem cells on damaged ovarian function. Lab Invest. 2013 Feb;93(2):181-93. doi: 10.1038/labinvest.2012.167. Epub 2012 Nov 19.

  PMID: 23212100 BACKGROUND

• Huang B, Lu J, Ding C, Zou Q, Wang W, Li H. Exosomes derived from human adipose mesenchymal stem cells improve ovary function of premature ovarian insufficiency by targeting SMAD. Stem Cell Res Ther. 2018 Aug 9;9(1):216. doi: 10.1186/s13287-018-0953-7.

  PMID: 30092819 BACKGROUND

• Shen J, Cao D, Sun JL. Ability of human umbilical cord mesenchymal stem cells to repair chemotherapy-induced premature ovarian failure. World J Stem Cells. 2020 Apr 26;12(4):277-287. doi: 10.4252/wjsc.v12.i4.277.

  PMID: 32399136 BACKGROUND

• Fazeli Z, Abedindo A, Omrani MD, Ghaderian SMH. Mesenchymal Stem Cells (MSCs) Therapy for Recovery of Fertility: a Systematic Review. Stem Cell Rev Rep. 2018 Feb;14(1):1-12. doi: 10.1007/s12015-017-9765-x.

  PMID: 28884412 BACKGROUND

• Bu S, Zhang Q, Wang Q, Lai D. Human amniotic epithelial cells inhibit growth of epithelial ovarian cancer cells via TGF-beta1-mediated cell cycle arrest. Int J Oncol. 2017 Nov;51(5):1405-1414. doi: 10.3892/ijo.2017.4123. Epub 2017 Sep 14.

  PMID: 29048644 BACKGROUND

• Herraiz S, Pellicer N, Romeu M, Pellicer A. Treatment potential of bone marrow-derived stem cells in women with diminished ovarian reserves and premature ovarian failure. Curr Opin Obstet Gynecol. 2019 Jun;31(3):156-162. doi: 10.1097/GCO.0000000000000531.

  PMID: 30855290 BACKGROUND

• Bhartiya D, Patel H. Ovarian stem cells-resolving controversies. J Assist Reprod Genet. 2018 Mar;35(3):393-398. doi: 10.1007/s10815-017-1080-6. Epub 2017 Nov 11.

  PMID: 29128912 BACKGROUND

• Vanni VS, Vigano P, Papaleo E, Mangili G, Candiani M, Giorgione V. Advances in improving fertility in women through stem cell-based clinical platforms. Expert Opin Biol Ther. 2017 May;17(5):585-593. doi: 10.1080/14712598.2017.1305352. Epub 2017 Mar 28.

  PMID: 28351161 BACKGROUND

• Farimani M, Heshmati S, Poorolajal J, Bahmanzadeh M. A report on three live births in women with poor ovarian response following intra-ovarian injection of platelet-rich plasma (PRP). Mol Biol Rep. 2019 Apr;46(2):1611-1616. doi: 10.1007/s11033-019-04609-w. Epub 2019 Feb 5.

  PMID: 30725347 BACKGROUND

• Ruhle A, Lopez Perez R, Zou B, Grosu AL, Huber PE, Nicolay NH. The Therapeutic Potential of Mesenchymal Stromal Cells in the Treatment of Chemotherapy-Induced Tissue Damage. Stem Cell Rev Rep. 2019 Jun;15(3):356-373. doi: 10.1007/s12015-019-09886-3.

  PMID: 30937640 BACKGROUND

• Zafardoust S, Kazemnejad S, Darzi M, Fathi-Kazerooni M, Rastegari H, Mohammadzadeh A. Improvement of Pregnancy Rate and Live Birth Rate in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived- Mesenchymal Stromal Cells: Phase I/II Clinical Trial. Stem Cell Rev Rep. 2020 Aug;16(4):755-763. doi: 10.1007/s12015-020-09969-6.

  PMID: 32198596 BACKGROUND

• Truman AM, Tilly JL, Woods DC. Ovarian regeneration: The potential for stem cell contribution in the postnatal ovary to sustained endocrine function. Mol Cell Endocrinol. 2017 Apr 15;445:74-84. doi: 10.1016/j.mce.2016.10.012. Epub 2016 Oct 12.

  PMID: 27743990 BACKGROUND

• Sheikhansari G, Aghebati-Maleki L, Nouri M, Jadidi-Niaragh F, Yousefi M. Current approaches for the treatment of premature ovarian failure with stem cell therapy. Biomed Pharmacother. 2018 Jun;102:254-262. doi: 10.1016/j.biopha.2018.03.056. Epub 2018 Mar 22.

  PMID: 29567538 BACKGROUND

• Soleimani R, Heytens E, Darzynkiewicz Z, Oktay K. Mechanisms of chemotherapy-induced human ovarian aging: double strand DNA breaks and microvascular compromise. Aging (Albany NY). 2011 Aug;3(8):782-93. doi: 10.18632/aging.100363.

  PMID: 21869459 BACKGROUND

• Galvez-Martin P, Sabata R, Verges J, Zugaza JL, Ruiz A, Clares B. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects. Stem Cells Int. 2016;2016:9783408. doi: 10.1155/2016/9783408. Epub 2016 Nov 24.

  PMID: 27999600 BACKGROUND

• Wang S, Yu L, Sun M, Mu S, Wang C, Wang D, Yao Y. The therapeutic potential of umbilical cord mesenchymal stem cells in mice premature ovarian failure. Biomed Res Int. 2013;2013:690491. doi: 10.1155/2013/690491. Epub 2013 Aug 13.

  PMID: 23998127 BACKGROUND

• Santiquet N, Vallieres L, Pothier F, Sirard MA, Robert C, Richard F. Transplanted bone marrow cells do not provide new oocytes but rescue fertility in female mice following treatment with chemotherapeutic agents. Cell Reprogram. 2012 Apr;14(2):123-9. doi: 10.1089/cell.2011.0066.

  PMID: 22471934 BACKGROUND

• Sun M, Wang S, Li Y, Yu L, Gu F, Wang C, Yao Y. Adipose-derived stem cells improved mouse ovary function after chemotherapy-induced ovary failure. Stem Cell Res Ther. 2013 Jul 9;4(4):80. doi: 10.1186/scrt231.

  PMID: 23838374 BACKGROUND

• Kilic S, Pinarli F, Ozogul C, Tasdemir N, Naz Sarac G, Delibasi T. Protection from cyclophosphamide-induced ovarian damage with bone marrow-derived mesenchymal stem cells during puberty. Gynecol Endocrinol. 2014 Feb;30(2):135-40. doi: 10.3109/09513590.2013.860127. Epub 2013 Dec 6.

  PMID: 24308768 BACKGROUND

• Frese L, Dijkman PE, Hoerstrup SP. Adipose Tissue-Derived Stem Cells in Regenerative Medicine. Transfus Med Hemother. 2016 Jul;43(4):268-274. doi: 10.1159/000448180. Epub 2016 Jul 26.

  PMID: 27721702 BACKGROUND

• Xia X, Wang T, Yin T, Yan L, Yan J, Lu C, Zhao L, Li M, Zhang Y, Jin H, Zhu X, Liu P, Li R, Qiao J. Mesenchymal Stem Cells Facilitate In Vitro Development of Human Preantral Follicle. Reprod Sci. 2015 Nov;22(11):1367-76. doi: 10.1177/1933719115578922. Epub 2015 Apr 7.

  PMID: 25854744 BACKGROUND

• Vural F, Vural B, Doger E, Cakiroglu Y, Cekmen M. Perifollicular blood flow and its relationship with endometrial vascularity, follicular fluid EG-VEGF, IGF-1, and inhibin-a levels and IVF outcomes. J Assist Reprod Genet. 2016 Oct;33(10):1355-1362. doi: 10.1007/s10815-016-0780-7. Epub 2016 Aug 2.

  PMID: 27484063 BACKGROUND

• Vahabi S, Yadegari Z, Mohammad-Rahimi H. Correction to: Comparison of the effect of activated or non-activated PRP in various concentrations on osteoblast and fibroblast cell line proliferation. Cell Tissue Bank. 2018 Sep;19(3):455. doi: 10.1007/s10561-017-9677-7.

  PMID: 29270824 BACKGROUND

• Pantos K, Nitsos N, Kokkali G, et al. Ovarian rejuvenation and folliculogenesis reactivation in peri-menopausal women after autologous platelet-rich plasma treatment. Abstracts, ESHRE 32nd Annual Meeting; 3-6 Jul 2016; Helsinki, Finland. Hum Reprod 2016 (Suppl. 1):i301.

  BACKGROUND

• Pines A, Sturdee DW, MacLennan AH. Quality of life and the role of menopausal hormone therapy. Climacteric. 2012 Jun;15(3):213-6. doi: 10.3109/13697137.2012.655923.

  PMID: 22612606 BACKGROUND

• Zollner YF, Acquadro C, Schaefer M. Literature review of instruments to assess health-related quality of life during and after menopause. Qual Life Res. 2005 Mar;14(2):309-27. doi: 10.1007/s11136-004-0688-z.

  PMID: 15892422 BACKGROUND

• Utian WH, Woods NF. Impact of hormone therapy on quality of life after menopause. Menopause. 2013 Oct;20(10):1098-105. doi: 10.1097/GME.0b013e318298debe.

  PMID: 23799357 BACKGROUND

• Hess R, Colvin A, Avis NE, Bromberger JT, Schocken M, Johnston JM, Matthews KA. The impact of hormone therapy on health-related quality of life: longitudinal results from the Study of Women's Health Across the Nation. Menopause. 2008 May-Jun;15(3):422-8. doi: 10.1097/gme.0b013e31814faf2b.

  PMID: 18467950 BACKGROUND

• Tella SH, Gallagher JC. Prevention and treatment of postmenopausal osteoporosis. J Steroid Biochem Mol Biol. 2014 Jul;142:155-70. doi: 10.1016/j.jsbmb.2013.09.008. Epub 2013 Oct 29.

  PMID: 24176761 BACKGROUND

• Greendale GA, Sowers M, Han W, Huang MH, Finkelstein JS, Crandall CJ, Lee JS, Karlamangla AS. Bone mineral density loss in relation to the final menstrual period in a multiethnic cohort: results from the Study of Women's Health Across the Nation (SWAN). J Bone Miner Res. 2012 Jan;27(1):111-8. doi: 10.1002/jbmr.534.

  PMID: 21976317 BACKGROUND

• Samargandy S, Matthews KA, Brooks MM, Barinas-Mitchell E, Magnani JW, Janssen I, Hollenberg SM, El Khoudary SR. Arterial Stiffness Accelerates Within 1 Year of the Final Menstrual Period: The SWAN Heart Study. Arterioscler Thromb Vasc Biol. 2020 Apr;40(4):1001-1008. doi: 10.1161/ATVBAHA.119.313622. Epub 2020 Jan 23.

  PMID: 31969013 BACKGROUND

• Greendale GA, Huang M, Cauley JA, Liao D, Harlow S, Finkelstein JS, Hans D, Karlamangla AS. Trabecular Bone Score Declines During the Menopause Transition: The Study of Women's Health Across the Nation (SWAN). J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1872-82. doi: 10.1210/clinem/dgz056.

  PMID: 31613958 BACKGROUND

• Randolph JF Jr, Zheng H, Sowers MR, Crandall C, Crawford S, Gold EB, Vuga M. Change in follicle-stimulating hormone and estradiol across the menopausal transition: effect of age at the final menstrual period. J Clin Endocrinol Metab. 2011 Mar;96(3):746-54. doi: 10.1210/jc.2010-1746. Epub 2010 Dec 15.

  PMID: 21159842 BACKGROUND

• Burger H. The menopausal transition--endocrinology. J Sex Med. 2008 Oct;5(10):2266-73. doi: 10.1111/j.1743-6109.2008.00921.x. Epub 2008 Jul 1.

  PMID: 18624962 BACKGROUND

• Greendale GA, Sternfeld B, Huang M, Han W, Karvonen-Gutierrez C, Ruppert K, Cauley JA, Finkelstein JS, Jiang SF, Karlamangla AS. Changes in body composition and weight during the menopause transition. JCI Insight. 2019 Mar 7;4(5):e124865. doi: 10.1172/jci.insight.124865. eCollection 2019 Mar 7.

  PMID: 30843880 BACKGROUND

• Karlamangla AS, Burnett-Bowie SM, Crandall CJ. Bone Health During the Menopause Transition and Beyond. Obstet Gynecol Clin North Am. 2018 Dec;45(4):695-708. doi: 10.1016/j.ogc.2018.07.012. Epub 2018 Oct 25.

  PMID: 30401551 BACKGROUND

• Sfakianoudis K, Simopoulou M, Nitsos N, Rapani A, Pappas A, Pantou A, Chronopoulou M, Deligeoroglou E, Koutsilieris M, Pantos K. Autologous Platelet-Rich Plasma Treatment Enables Pregnancy for a Woman in Premature Menopause. J Clin Med. 2018 Dec 20;8(1):1. doi: 10.3390/jcm8010001.

  PMID: 30577435 BACKGROUND

MeSH Terms

Conditions

Endocrine System Diseases

Interventions

Saline Solution; Injections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 23, 2020
• Study Start: July 15, 2022
• Primary Completion: September 30, 2024
• Study Completion: August 15, 2025
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)