Premature Ovarian FailurePhase 1/2NCT02644447
Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF
A Phase 1/2 study testing HUC-MSCs Transplantation and HUC-MSCs with Injectable Collagen Scaffold Transplantation in people with Premature Ovarian Failure, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 20 to 39 years, women only
- Conditions the study is for
- Premature Ovarian Failure
- What is being tested?
- HUC-MSCs Transplantation and HUC-MSCs with Injectable Collagen Scaffold Transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Premature Ovarian Failure.
- Patients show no response to drug treatment
- Women between 20 and 39 years.
- Willing to sign the Informed Consent Form.
Who cannot join
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
- Congenital ovarian malformation.
- Severe endometriosis.
- Thyroid dysfunction.
- Contraindications for pregnancy.
- Contraindications for hormone replacement therapy.
- Prior personal history of ovarian cancer or after radiotherapy.
- Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)
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.
Read the detailed description
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
- Premature Ovarian Failure
- Being tested
- HUC-MSCs Transplantation, HUC-MSCs with Injectable Collagen Scaffold Transplantation
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HUC-MSCs TransplantationBiological
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
HUC-MSCs with Injectable Collagen Scaffold TransplantationBiological
The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.
| Study group | Role | What they receive |
|---|---|---|
| HUC-MSCs Transplantation | Experimental | Not described Receives: Biological: HUC-MSCs Transplantation |
| HUC-MSCs with Injectable Collagen Scaffold Transplantation | Experimental | Not described Receives: Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability assessed by Adverse Events
Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.
Measured: Up to 6 months
Secondary outcomes (5)
Number of Antral follicle development
The number of follicles developing was recorded by transvaginal ultrasound scan.
Measured: Once a week within 3 months after the surgery
Estradiol (E2) serum level
Serum E2 level was evaluated after surgery.
Measured: Once a week within 3 months after the surgery
Follicle Stimulating Hormone (FSH) serum level
Serum FSH level was evaluated after surgery.
Measured: Once a week within 3 months after the surgery
Anti-Mullerian Hormone (AMH) serum level
Serum AMH level was evelated after surgery.
Measured: Once a week within 3 months after the surgery
Pregnancy rate
The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
Measured: 2 weeks after embryo implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644447
- Sponsor's protocol ID
- CAS-XDA-POF/IGDB
- Status last verified
- Dec 2015
- First submitted
- 28 Dec 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) With Injectable Collagen Scaffold Transplantation in Woman With Premature Ovarian Failure (POF)
- ClinicalTrials.gov ID
- NCT02644447
- Acronym / sponsor ID
- CAS-XDA-POF/IGDB
- Conditions
- Premature Ovarian Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 31 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUC-MSCs Transplantation | Experimental | Biological: HUC-MSCs Transplantation |
| HUC-MSCs with Injectable Collagen Scaffold Transplantation | Experimental | Biological: HUC-MSCs with Injectable Collagen Scaffold Transplantation |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with Premature Ovarian Failure.
- Patients show no response to drug treatment
- Women between 20 and 39 years.
- Willing to sign the Informed Consent Form.
Key exclusion criteria (8 listed)
- Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
- Congenital ovarian malformation.
- Severe endometriosis.
- Thyroid dysfunction.
- Contraindications for pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HUC-MSCs TransplantationThe patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs. | Biological | HUC-MSCs Transplantation |
| HUC-MSCs with Injectable Collagen Scaffold TransplantationThe patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold. | Biological | HUC-MSCs with Injectable Collagen Scaffold Transplantation |
Primary outcome
Safety and Tolerability assessed by Adverse Events
Time frame: Up to 6 months
Proportion of patients with postoperative infections and serious adverse events (SAEs) were assessed by long term follow-up.
5 secondary outcomes
Number of Antral follicle development
Time frame: Once a week within 3 months after the surgery
Estradiol (E2) serum level
Time frame: Once a week within 3 months after the surgery
Follicle Stimulating Hormone (FSH) serum level
Time frame: Once a week within 3 months after the surgery
Anti-Mullerian Hormone (AMH) serum level
Time frame: Once a week within 3 months after the surgery
Pregnancy rate
Time frame: 2 weeks after embryo implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianwu Dai, Ph.D principal investigator
Chinese Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HUC-MSCs Transplantation and HUC-MSCs with Injectable Collagen Scaffold Transplantation in people with Premature Ovarian Failure, run by Chinese Academy of Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability assessed by Adverse Events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.