Peripheral Vascular DiseasePhase 1NCT02834858
Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications
A Phase 1 study testing Umbilical Cord Mesenchymal Stem Cells and saline in people with Peripheral Vascular Disease and Ischemia, run by Jie Shen at 1 site in China.
Trial summary
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Vascular Disease, Ischemia, Diabetic Foot
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cells and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2019
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus Type 2 or Type 1
- Age between 18-80 years
- Chronic foot ulcer more than 6 weeks
- No sufficient response to best standard care delivered for six weeks.
- PAD up to Fontaine stage III or IV period
- CLI with the ankle brachial index (index ankle-brachial, ABI) <0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) <30mmHg
Who cannot join
- HbA1c >12%
- Hemoglobin <10 mg/dl
- Creatinine clearance rate <30ml/min
- Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis
- Have accepted the treatment of stem cells or growth factors
- Have a history of malignant disease
Show all 12Show fewer
- Pregnancy
- Mental illness history
- Abnormal coagulation function
- Allergic reaction
- Severe cardiac insufficiency (III-IV NYHA)
- Using vasoactive substances
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
zhang qun, 020-62784060, Zq1979@smu.edu.cn
Jie Shen
About this study
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
Read the detailed description
Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of the investigators research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
- Conditions
- Peripheral Vascular Disease, Ischemia, Diabetic Foot
- Being tested
- Umbilical Cord Mesenchymal Stem Cells, saline
- Keywords
- Umbilical Cord Mesenchymal Stem Cells
- Medical subject headings
- Peripheral Vascular Diseases, Ischemia, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem CellsBiological
stem cell acquisition, processing and reinfection, to evaluate the efficacy by using umbilical cord mesenchymal stem cells
salineBiological
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells | Experimental | Umbilical Cord Mesenchymal Stem Cells Infusion. Receives: Biological: Umbilical Cord Mesenchymal Stem Cells |
| saline | Placebo comparator | saline injection Receives: Biological: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area of diabetic foot ulcers
To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
Measured: 3 months
Secondary outcomes (4)
Improvement of transcutaneous oxygen partial pressure (TcPO2)
Improvement of local perfusion.
Measured: 3 months
Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)
Measured: 3 months
Pain (Visual-Analog Scale)
Measure of the subjective symptom of pain.
Measured: 3 months
Walking distance (treadmill) if possible
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Shen
- Sponsor type
- Other government
- Collaborators
- Nanfang Hospital, Southern Medical University, Academy Military Medical Science, China, The Fifth Affiliated Hospital of Southern Medical University, Southern Medical University, China
- Responsible party
- Sponsor-investigator, Jie Shen, The Third Affiliated Hospital of Southern Medical University
- Investigators
- Jie Shen, Principal investigator, The Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834858
- Sponsor's protocol ID
- ThirdSouthernMedical1
- Status last verified
- Apr 2017
- First submitted
- 9 Jul 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Mesenchymal Stem Cells Infusion for Diabetes Related Vascular Complications
- ClinicalTrials.gov ID
- NCT02834858
- Acronym / sponsor ID
- ThirdSouthernMedical1
- Conditions
- Peripheral Vascular Disease, Ischemia, Diabetic Foot
- Keywords
- Umbilical Cord Mesenchymal Stem Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jie ShenOther government
- Collaborators
- Nanfang Hospital, Southern Medical University, Academy Military Medical Science, China, The Fifth Affiliated Hospital of Southern Medical University, Southern Medical University, China
- Study start
- Jan 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Jul 2016 (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.
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
Detailed description
Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.
Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of the investigators research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells | Experimental | Biological: Umbilical Cord Mesenchymal Stem CellsUmbilical Cord Mesenchymal Stem Cells Infusion. |
| saline | Placebo comparator | Biological: salinesaline injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus Type 2 or Type 1
- Age between 18-80 years
- Chronic foot ulcer more than 6 weeks
- No sufficient response to best standard care delivered for six weeks.
- PAD up to Fontaine stage III or IV period
Key exclusion criteria (12 listed)
- HbA1c >12%
- Hemoglobin <10 mg/dl
- Creatinine clearance rate <30ml/min
- Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, - HIV, B19 infection, herpes virus infection) and sepsis
- Have accepted the treatment of stem cells or growth factors
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 |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cellsstem cell acquisition, processing and reinfection, to evaluate the efficacy by using umbilical cord mesenchymal stem cells | Biological | Umbilical Cord Mesenchymal Stem Cells |
| saline | Biological | saline |
Primary outcome
Area of diabetic foot ulcers
Time frame: 3 months
To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.
4 secondary outcomes
Improvement of transcutaneous oxygen partial pressure (TcPO2)
Time frame: 3 months
Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)
Time frame: 3 months
Pain (Visual-Analog Scale)
Time frame: 3 months
Walking distance (treadmill) if possible
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Jie Shen principal investigator
The Third Affiliated Hospital of Southern Medical University
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 Umbilical Cord Mesenchymal Stem Cells and saline in people with Peripheral Vascular Disease and Ischemia, run by Jie Shen 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 6 inclusion and 12 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 6 Apr 2017. 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. Some participants in this study may receive a placebo. 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 Jie Shen (+86 13808893818, shenjiedr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area of diabetic foot ulcers (time frame: 3 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 6 Apr 2017.