Diabetic Foot UlcerPhase 1NCT04464213
Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
A Phase 1 study testing Single dose experiments and Multi-dose experiments in people with Diabetic Foot Ulcer, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
This study is designated to: 1. investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer. 2. learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer. 3. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Single dose experiments and Multi-dose experiments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 Dec 2023
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and Age ≤ 75
- Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
- Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
- Full understand the informed consent form, and signed it voluntarily
Who cannot join
- Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
- Be allergic to any component of the drug or showed allergic constitution
- Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
- Have malignancy in the ulcer pathology test, or have a history of malignant tumor
- Unable to clean the wounds due to the formation of tract between the ulcer and other condition
- Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum
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- Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr>200 μmol/L
- Have a history of apoplexy, unstable angina pectoris, myocardial infarct
- Have a psychiatric history, drug abuse or alcohol abuse history
- Had participated in any other clinical trials in the past 3 months
- Any other circumstances judged by the researchers disqualify the patient to participate in the trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University
Beijing, Beiijng, 100730
Siyang Ni, Doc, +（86）-18911810275, grandnsy@163.com
About this study
Official title: Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
This study is designated to:
- investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer.
- learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
- study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Single dose experiments, Multi-dose experiments
- Keywords
- Human placental mesenchymal stem cells, Gel
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose experimentsOther
In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.
Multi-dose experimentsOther
In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Single dose experiments | Experimental | Not described Receives: Other: Single dose experiments |
| Multi-dose experiments | Experimental | Not described Receives: Other: Multi-dose experiments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse event
The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Measured: 0 hour - 24 hours
Rate of adverse event
The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Measured: 0 Day - 7 Days
Secondary outcomes (2)
Rate of serious adverse event
The rate of serious adverse event in 1 hour after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Measured: 0 hour - 1 hour
Rate of cure rate
Rate of cure rate in 20 days and 34 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Measured: 0 day - 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Nov 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuli Zhao, Doc, Principal investigator, Beijing Tongren Hospital, CMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464213
- Sponsor's protocol ID
- HS201901
- Status last verified
- Dec 2021
- First submitted
- 7 Jul 2020
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trials of Human Placental Mesenchymal Stem Cells Treatment on Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT04464213
- Acronym / sponsor ID
- HS201901
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Human placental mesenchymal stem cells, Gel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jul 2020 (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.
This study is designated to:
- investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer.
- learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
- study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose experiments | Experimental | Other: Single dose experiments |
| Multi-dose experiments | Experimental | Other: Multi-dose experiments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and Age ≤ 75
- Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
- Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
- Full understand the informed consent form, and signed it voluntarily
Key exclusion criteria (11 listed)
- Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
- Be allergic to any component of the drug or showed allergic constitution
- Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
- Have malignancy in the ulcer pathology test, or have a history of malignant tumor
- Unable to clean the wounds due to the formation of tract between the ulcer and other condition
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 |
|---|---|---|
| Single dose experimentsIn single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time. | Other | Single dose experiments |
| Multi-dose experimentsIn multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days. | Other | Multi-dose experiments |
Primary outcome
Rate of adverse event
Time frame: 0 hour - 24 hours
The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
Rate of adverse event
Time frame: 0 Day - 7 Days
The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
2 secondary outcomes
Rate of serious adverse event
Time frame: 0 hour - 1 hour
Rate of cure rate
Time frame: 0 day - 34 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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EDX110 Randomized Control Trial for Treatment of DFUs
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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.
Xiuli Zhao, Doc principal investigator
Beijing Tongren Hospital, CMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single dose experiments and Multi-dose experiments in people with Diabetic Foot Ulcer, run by Beijing Tongren Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siyang Ni, Doc (+(86)-18911810275, grandnsy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adverse event (time frame: 0 hour - 24 hours). The study lists 2 primary outcomes in all. 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 21 Oct 2022.