Stem Cell Transplant ComplicationsPhase 1/2NCT03985462
Very Small Embryonic-like Stem Cells for Ovary
A Phase 1/2 study testing very small embryonic-like stem cell in people with Stem Cell Transplant Complications and Premature Ovarian Failure, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Stem Cell Transplant Complications, Premature Ovarian Failure
- What is being tested?
- very small embryonic-like stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2019to 30 Jun 2020
- 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 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients who are diagnosed as premature ovarian failure by professional doctor.
- Those have clear abnormal sex hormone levels
Who cannot join
- Unmarried woman
- Suffering from other serious gynecological diseases or gynecological tumors
- Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
Trial locations and contacts
1 site in 1 country.
China1 site
Biological treatment center in Fuda cancer hospital
Guangzhou, Guangdong, 510000
About this study
Official title: Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.
Read the detailed description
Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, > 40 IU/L)、luteinizing hormon (LH, > 40 IU/L)、estradiol (E2, > 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.
- Being tested
- very small embryonic-like stem cell
- 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.
very small embryonic-like stem cellBiological
Also called VSEL
Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
| Study group | Role | What they receive |
|---|---|---|
| VSEL Max | Experimental | A total of 300,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a high dose group Receives: Biological: very small embryonic-like stem cell |
| VSEL Medium | Experimental | A total of 200,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a middle dose group Receives: Biological: very small embryonic-like stem cell |
| VSEL Mini | Experimental | A total of 100,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a low dose group Receives: Biological: very small embryonic-like stem cell |
| Control | No intervention | 5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Blood female hormones level
Check whether blood FSH, LH and E2 levels return to normal
Measured: 1 month after injection
Secondary outcomes (4)
Concentration of Blood female hormones level
Check whether blood FSH, LH and E2 levels return to normal
Measured: 6 months after injection
Incidence of amenorrhea
Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound
Measured: 6 months after injection
Concentration of Blood female hormones level
Check whether blood FSH, LH and E2 levels return to normal
Measured: 12 months after injection
Incidence of amenorrhea
Inquire about menstrual condition and exam ovarian blood supply by gynecological color ultrasound
Measured: 12 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start3 Jul 2019
- Primary completion30 May 2020
- Study completion30 Jun 2020
Why it stopped: Policy changes have contributed to the failure to carry out smoothly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies 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
- Model description
- Patients with confirmed premature ovarian failure were divided into three groups, each group was injected with different numbers of VSEL cells, and the control group was injected with platelet-rich serum which is the cell solvent
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985462
- Sponsor's protocol ID
- VSEL-ovary
- Status last verified
- May 2020
- First submitted
- 1 Jun 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
- ClinicalTrials.gov ID
- NCT03985462
- Acronym / sponsor ID
- VSEL-ovary
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Policy changes have contributed to the failure to carry out smoothly
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Collaborators
- Guangzhou Four-Leaf Clover HealthTech Co., Ltd.
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 13 Jun 2019 (actual)
- 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.
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.
Detailed description
Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, > 40 IU/L)、luteinizing hormon (LH, > 40 IU/L)、estradiol (E2, > 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Patients with confirmed premature ovarian failure were divided into three groups, each group was injected with different numbers of VSEL cells, and the control group was injected with platelet-rich serum which is the cell solvent
| Arm | Type | Receives |
|---|---|---|
| VSEL Max | Experimental | Biological: very small embryonic-like stem cellA total of 300,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a high dose group |
| VSEL Medium | Experimental | Biological: very small embryonic-like stem cellA total of 200,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a middle dose group |
| VSEL Mini | Experimental | Biological: very small embryonic-like stem cellA total of 100,000 VSEL cells in 5 mL plate-rich plasma are injected into the bilateral fallopian tubes as a low dose group |
| Control | No intervention | –5 mL plate-rich plasma with no cells inside were injected into the bilateral fallopian tubes as a control group |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients who are diagnosed as premature ovarian failure by professional doctor.
- Those have clear abnormal sex hormone levels
Key exclusion criteria (3 listed)
- Unmarried woman
- Suffering from other serious gynecological diseases or gynecological tumors
- Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
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 |
|---|---|---|
| very small embryonic-like stem cellAlso: VSELMononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation | Biological | VSEL Max, VSEL Medium, VSEL Mini |
Primary outcome
Concentration of Blood female hormones level
Time frame: 1 month after injection
Check whether blood FSH, LH and E2 levels return to normal
4 secondary outcomes
Concentration of Blood female hormones level
Time frame: 6 months after injection
Incidence of amenorrhea
Time frame: 6 months after injection
Concentration of Blood female hormones level
Time frame: 12 months after injection
Incidence of amenorrhea
Time frame: 12 months after injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Stem Cell Transplant Complications
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Not yet recruitingPhase 1
Expanded Donor Stem Cells for Poor Graft Function After Stem Cell Transplantation in Children
Poor Graft Function, Hematopoietic Stem Cell Transplantation Complications
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
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.
The record lists no contact. Use the official record to reach the sponsor.
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 very small embryonic-like stem cell in people with Stem Cell Transplant Complications and Premature Ovarian Failure, run by Fuda Cancer Hospital, Guangzhou 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Oct 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 was withdrawn before enrolling participants, so there are no results.
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?
Concentration of Blood female hormones level (time frame: 1 month after injection). 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 19 Oct 2020.