Transplantation of HUC-MSCs With Injectable Collagen Scaffold for 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of UCA-PSCs in Women With POF

NCT05138367

Premature Ovarian Failure

COMPLETED PHASE1

Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)

NCT03033277

Primary Ovarian Insufficiency

UNKNOWN PHASE1/PHASE2

Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency

NCT05308342

Premature Ovarian Insufficiency

UNKNOWN NA

Mesenchymal Stem Cells (MSCs) - Like Cell Transplantation in Women With Primary Ovarian Insufficiency

NCT03877471

Primary Ovarian Insufficiency

UNKNOWN PHASE1

The Safety and Efficiency Study of Mesenchymal Stem Cell (19#iSCLife®-POI) in Premature Ovarian Insufficiency

NCT03816852

Premature Ovarian Failure

SUSPENDED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with injectable collagen scaffold transvaginal injection for POF women. The serum of each patient was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral ovaries. The outcomes of patients were examined after the injection. The patients are monitored for signs of follicle growth and growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Ovarian Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HUC-MSCs Transplantation

Group Type EXPERIMENTAL

HUC-MSCs Transplantation

Intervention Type BIOLOGICAL

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.

HUC-MSCs with Injectable Collagen Scaffold Transplantation

Group Type EXPERIMENTAL

HUC-MSCs with Injectable Collagen Scaffold Transplantation

Intervention Type BIOLOGICAL

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HUC-MSCs Transplantation

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.

Intervention Type BIOLOGICAL

HUC-MSCs with Injectable Collagen Scaffold Transplantation

The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Diagnosed with Premature Ovarian Failure.
2. Patients show no response to drug treatment
3. Women between 20 and 39 years.
4. Willing to sign the Informed Consent Form.

Exclusion Criteria

1. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
2. Congenital ovarian malformation.
3. Severe endometriosis.
4. Thyroid dysfunction.
5. Contraindications for pregnancy.
6. Contraindications for hormone replacement therapy.
7. Prior personal history of ovarian cancer or after radiotherapy.
8. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No