Diabetic FootPhase 1NCT02304588
Stem Cell Therapy for Patients With Vascular Occlusive Diseases Such as Diabetic Foot
A Phase 1 study testing Mesenchymal stem cells in people with Diabetic Foot and Lower Limb Ischemia, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow. Read more about this study
- Who is it for?
- Ages 30 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot, Lower Limb Ischemia
- What is being tested?
- Mesenchymal stem cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Dec 2017
- 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 30 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the age of 30-78 years old, men and women there is no limit.
- in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
- with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
- treatment on a voluntary basis, and sign the informed consent.
Who cannot join
- with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
- clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
- the prodrome of acute infectious diseases.
- participated in clinical subjects within three months before test.
- adherence is poor, can not complete the course.
Trial locations and contacts
1 site in 1 country.
xiaobing FU contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
haojie Hao, +86(10)937516
haojie Hao, +86(10)937516, haojieh@163.com
About this study
Official title: Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.
- Conditions
- Diabetic Foot, Lower Limb Ischemia
- Being tested
- Mesenchymal stem cells
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsBiological
10-20 x 10^6 cells/20mL
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells | Experimental | Maximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size \& patient weight). Receives: Biological: Mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Frequency and severity of Adverse Events
Measured: 6 months
Secondary outcomes (1)
Relative Wound Area Regression of 40% or More at 6 Week
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJan 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobing Fu, Chinese PLA General Hospital
- Investigators
- xiaobing FU, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304588
- Sponsor's protocol ID
- CHIN-PLAGH-ST-001
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Occlusive Diseases Such as Diabetic Foot Treated With Mesenchymal Stem Cell
- ClinicalTrials.gov ID
- NCT02304588
- Acronym / sponsor ID
- CHIN-PLAGH-ST-001
- Conditions
- Diabetic Foot, Lower Limb Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Dec 2014 (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.
Mesenchymal stem cells with multidirectional differentiation potential,autologous stem cell transplantation into ischemic foot, make its differentiation to form new blood capillary, improve and restore the local blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells | Experimental | Biological: Mesenchymal stem cellsMaximal amount of MSC cells injected: 10-20*10^6 cells (up to volume of 20mL, depending on the wound size \& patient weight). |
Who may qualify
- Ages
- 30 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the age of 30-78 years old, men and women there is no limit.
- in accordance with the ministry of health in higher medical colleges and universities teaching material the sixth edition of the annals of diabetic foot diagnostic criteria.
- with severe lower limb ischemia (defined as the resting state of ankle brachial index (ABI) 0.4-0.85, accompanied by resting or intermittent toe line.
- treatment on a voluntary basis, and sign the informed consent.
Key exclusion criteria (5 listed)
- with severe heart, liver, kidney, lung function failure or general condition is very poor can't tolerate the stem cell transplant.
- clear over the past five years tumor markers in patients with malignant disease and blood levels increased significantly.
- the prodrome of acute infectious diseases.
- participated in clinical subjects within three months before test.
- adherence is poor, can not complete the course.
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 |
|---|---|---|
| Mesenchymal stem cells10-20 x 10^6 cells/20mL | Biological | Mesenchymal stem cells |
Primary outcome
Frequency of Adverse Events
Time frame: 6 months
Frequency and severity of Adverse Events
1 secondary outcome
Relative Wound Area Regression of 40% or More at 6 Week
Time frame: 6 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
xiaobing FU contact
xiaobing FU principal investigator
Chinese PLA General Hospital
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 Mesenchymal stem cells in people with Diabetic Foot and Lower Limb Ischemia, run by Chinese PLA General 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 5 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 2 Dec 2014. 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 xiaobing FU (+86(10)937516), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: 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 2 Dec 2014.