Diabetic FootPhase 1/2NCT01216865
Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
A Phase 1/2 study testing umbilical cord mesenchymal stem cells and Standard Therapy in people with Diabetic Foot and Critical Limb Ischemia, run by Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Foot, Critical Limb Ischemia, Mesenchymal Stem Cells
- What is being tested?
- umbilical cord mesenchymal stem cells and Standard Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Jul 2013
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus Type 2
- Age 18 - 75 years
- Subject has an Ankle-brachial index < 0.9
- Subject has had previous conservative treatment which resulted in little or no improvement
- Subject has had no stem cell treatment within the past 6 months
- No sufficient response to best standard care delivered for six weeks.
Show all 11Show fewer
- No surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon and an interventional radiologist
- Signed informed consent
- Absence of life-threatening complications from the ischemic limb
- Life expectancy more than 2 years
- Negative pregnancy test when applicable
Who cannot join
- Diabetic retinopathy
- History of neoplasm or hematological disease
- Uncontrolled high blood pressure (>180/110)
- Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
- Malignant ventricular arrythmia
- Deep venous thrombosis during the last 3 months
Show all 9Show fewer
- Active bacterial infection
- Body mass index > 35 Kg/m2
- Stroke or myocardial infarction during the last 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, 266003
Jianxia Hu, MD, 86-0532-82911676, qdyxyhjx@126.com
Hong Gao, MS, 86-0532-82911676, honggaogloria@gmail.com
About this study
Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
Read the detailed description
Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).
- Being tested
- umbilical cord mesenchymal stem cells, Standard Therapy
- Keywords
- Diabetic foot, critical limb ischemia, mesenchymal stem cells, umbilical cord
- Medical subject headings
- Diabetic Foot, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord mesenchymal stem cellsBiological
Also called mesenchymal stem cells
5*10/7 per ischemic limb
Standard TherapyDrug
Also called Drug therapy
Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. Receives: Biological: umbilical cord mesenchymal stem cells |
| Standard Therapy | Active comparator | Any therapy for diabetic foot which is routinely practiced and accepted in China Receives: Drug: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic evaluation of angiogenesis at ischemic limb
Measured: 6 months
Secondary outcomes (5)
Pain
Measured: 3 months
Ankle-Brachial pressure index
Measured: 3 months
Wound healing (wound size, wound stage)
Measured: 3 months
Walking distance
Measured: 3 months
Rate and extent of amputations
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (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.
- 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Investigators
- Yangang Wang, MD Phd, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01216865
- Sponsor's protocol ID
- MSCDF001
- Status last verified
- Jan 2009
- First submitted
- 6 Oct 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic Foot
- ClinicalTrials.gov ID
- NCT01216865
- Acronym / sponsor ID
- MSCDF001
- Keywords
- Diabetic foot, critical limb ischemia, mesenchymal stem cells, umbilical cord
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 7 Oct 2010 (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.
The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for diabetic foot is safe and effective in the management of diabetic foot ischemia, the therapeutic effect of stem cells is caused by improving blood circulation in ischemic limb which would in turn promote ulcer healing, prevent amputation of limb and relieve the Sevier pain of ischemia.
Detailed description
Type 2 diabetic patients with diabetic foot were enrolled and randomized to either transplanted group or control group. Patients in transplanted group received the stem cells treatment,Patients in control group received the standard treatment. After culture in vitro, umbilical cord mesenchymal stem cells should go through safety evaluation which include culture and check of pathogenic microorganisms (bacteria, mycoplasma, chlamydia, eumycete and viruses) of the cells medium and karyotype analysis of the mesenchymal stem cells. Only the safe cells were harvested and transplanted by multiple intramuscular injections into the impaired lower limbs. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,magnetic resonance angiography,electromyogram) and safety (infection of the injection site, fever, and tumour generation).
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 cellsMultiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord. |
| Standard Therapy | Active comparator | Drug: Standard TherapyAny therapy for diabetic foot which is routinely practiced and accepted in China |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diabetes mellitus Type 2
- Age 18 - 75 years
- Subject has an Ankle-brachial index < 0.9
- Subject has had previous conservative treatment which resulted in little or no improvement
- Subject has had no stem cell treatment within the past 6 months
Key exclusion criteria (9 listed)
- Diabetic retinopathy
- History of neoplasm or hematological disease
- Uncontrolled high blood pressure (>180/110)
- Severe cardiac insufficiency (New York Heart Association [NYHA] IV) or ejection fraction<30%
- Malignant ventricular arrythmia
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 cellsAlso: mesenchymal stem cells5*10/7 per ischemic limb | Biological | umbilical cord mesenchymal stem cells |
| Standard TherapyAlso: Drug therapyAny thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc | Drug | Standard Therapy |
Primary outcome
Angiographic evaluation of angiogenesis at ischemic limb
Time frame: 6 months
5 secondary outcomes
Pain
Time frame: 3 months
Ankle-Brachial pressure index
Time frame: 3 months
Wound healing (wound size, wound stage)
Time frame: 3 months
Walking distance
Time frame: 3 months
Rate and extent of amputations
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Yangang Wang, MD Phd study director
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing umbilical cord mesenchymal stem cells and Standard Therapy in people with Diabetic Foot and Critical Limb Ischemia, run by Qingdao University 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 11 inclusion and 9 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 13 Oct 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianxia Hu, MD (86-0532-82911676, qdyxyhjx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiographic evaluation of angiogenesis at ischemic limb (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 13 Oct 2010.