Autologous Adipose Derived Mesenchymal Stromal Cells Transplantation in Women With Premature Ovarian Failure (POF)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2018-11-30

Brief Summary

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The goal of this study is to determine safety and tolerability and of intra-ovarian injection of adipose derived stromal cell in women with premature ovarian failure and to study the preliminary efficacy ADSCs intra ovarian injection on ovarian function improvement.

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Detailed Description

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In this study 9 patients with the diagnosis of premature ovarian failure will participate.

The patients will be divided randomly in 3 groups, each group contains 3 patients. First group will receive 5 millions of ADSCs, second group receive 10 millions cells and the third group receive 15millions of ADSCs.

Stem cell Transplantation method is intraovarian injection of ADSCs which will be performed under guidance of transvaginal sonography.

All the patients will be followed for 12 months after cell injection to evaluate any adverse events .

Conditions

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Premature Ovarian Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5 million MSC

The patients with POF who underwent intraovarian injection of 5 million mesenchymal stem cells.

Group Type EXPERIMENTAL

Intraovarian injection of Adipose derived Stromal cells (ADSCs)

Intervention Type BIOLOGICAL

Intra-ovarian injection of Adipose derived mesenchymal stem cells.

10 million MSC

The patients with POF who underwent intraovarian injection of 10 million mesenchymal stem cells.

Group Type EXPERIMENTAL

Intraovarian injection of Adipose derived Stromal cells (ADSCs)

Intervention Type BIOLOGICAL

Intra-ovarian injection of Adipose derived mesenchymal stem cells.

15 million MSC

The patients with POF who underwent intraovarian injection of 15 million mesenchymal stem cells.

Group Type EXPERIMENTAL

Intraovarian injection of Adipose derived Stromal cells (ADSCs)

Intervention Type BIOLOGICAL

Intra-ovarian injection of Adipose derived mesenchymal stem cells.

Interventions

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Intraovarian injection of Adipose derived Stromal cells (ADSCs)

Intra-ovarian injection of Adipose derived mesenchymal stem cells.

Intervention Type BIOLOGICAL

Other Intervention Names

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stem cell transplantation

Eligibility Criteria

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Inclusion Criteria

* female
* Age : 20-39
* FSH\>20

Exclusion Criteria

* liposuction contraindication
* thyroid dysfunction
* immune system disease
* past history of cancer , chemotherapy , radiotherapy
* HIV+, hepatitis B, C
* Severe endometriosis

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hamid Gourabi, PhD

Role: STUDY_CHAIR

Head of Royan Institute

Tahereh Madani, MD

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.

Mehri Mashayekhi, MD

Role: STUDY_DIRECTOR

Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.