Cell Therapy for Infertility Patients with Implantation Failure using Adipose Tissue Derived Regenerative Cells

Phase 2

• Conditions: Implantation failure; infertility, implantation failure

• Registration Number: JPRN-jRCTb070200001
• Lead Sponsor: Miyamoto Shingo

Brief Summary

Intrauterine AMCUE infusion is safe procedure, however didn't demonstrate the positive effects of endometrial proliferation and implantation rate on infertility patients with implantation failure.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Study Completion: 2021-06-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1

Inclusion Criteria

1)Patients who are diagnosed with infertility.
2)Patients who are suspected of embryo implantation failure.
3)Patients who require artificial reproductive technology.
4)Patients who have enough restoring potential to keep various organs ordinary condition. The data are acceptable within 3 months before the entry of clinical trial.
(1)White blood cell > 3,000/microl, Neutrophil > 1,000/microl
(2)Platelet > 100,000/microl
(3)Hemoglobin > 10.0 g/dl
(4)AST, ALT < 100 U/l (IU/l)
(5)Serum creatinine < 1.0 mg/dl
(6)Total bilirubin < 1.0 mg/dl
(7)Patients with no definite cardiac dysfunction
(8)Patients with D-Dimer <1.0 mg/dl or patients with D-Dimer >1.0 mg/dl and no deep vein thrombosis examined by lower extremity ultrasound
(9)PT <15 sec.
(10) APTT 24-38 sec.
5)Age => 20 years.
6)Patients who have the oocytes and blastocysts vitrified after insemination by sperm from her husband.
7)Patients and their husband who agree to attend this clinical trial by their own will.

Exclusion Criteria

1)Patients who have serious illness or suspect to have serious illness mentioned below.
2)Patients who need psychotic therapy or who take psychiatric medication.
3)Patients with poorly-controlled diabetes.
4)Patients with active or poorly-controlled serious infection.
5)Patients with the diseases getting worse due to pregnancy.
6)Patients with inflammatory diseases or neoplastic lesion in endometrium.
7)Patients with serious drug hypersensitivity.
8)Patient with multiple malignancies or with those history 5 years (without intraepithelial neoplasm)
9)Patients who hope to use other oocytes and blastocysts, not their own oocytes and blastocysts.
10)Patient with malignancy or taking chemotherapy, radiation therapy or other cancer therapy.
11)Patients with serious diseases, for example, cardiac diseases, pulmonary diseases, liver diseases, kidney diseases, hemorrhagic diathesis, sepsis, poorly-controlled diabetes and hypertension and so on).
12)Patients who take anticoagulant or antiplatelet drugs, or inhibitors of GP IIb/IIIa.
13)Patients who take anticoagulant drug within 1 hour before harvesting their adipose tissues.
14)Patients with an elevated APTT more than 1.8 times of normal range.
15)Patients with active infection including HIV, syphilis, hepatitis B and C.
16)Pregnant women, nursing mothers, or patients with chance of pregnancy.
17)Patients undergoing other stem cell therapy.
18)Patient that principal investigator or sub investigators judged the participation in this clinical trial to be inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
#1. Measurement of endometrium thickness using transvaginal ultrasound before and after intrauterine implantation of Autologous Adipose Tissue Derived Regenerative Cells.<br>#2. Conformation of pregnancy performed by pregnancy test and detection of gestational sac and fetus inside the uterus using transvaginal ultrasound.

Secondary Outcome Measures

Name	Time	Method
Investigation of safety in intrauterine implantation of Autologous Adipose Tissue Derived Regenerative Cells.