Diabetic Foot UlcerPhase 1NCT02394886
Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers
A Phase 1 study testing ALLO-ASC-DFU in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- ALLO-ASC-DFU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Jul 2015
- 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
- Subject is between 18 and 80 years of age.
- Subject is diagnosed with Type I or Type II diabetes.
- Subjects who have a wound defined as diabetic foot ulcer presence for more than 4 weeks, but not present for more than 54 weeks at the screening visit.
- Foot ulcer located below the malleoli on plantar or dorsal surface of the foot and ulcer size is between 1 cm^2 and 25 cm^2.
- Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
- Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made of primarily vascularized tissue.
- 0.7 < Ankle Brachial Index (ABI) < 1.3.
- Subject is able to give written informed consent prior to study start and to comply with the study requirements.
Who cannot join
- Ulcer is of non-diabetic pathophysiology.
- Gangrene is present on any part of the affected foot.
- Ulcer is over an active Charcot deformity.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- The longest dimension of the Index Ulcer exceeds 5 cm at the screening visit.
- Subject is Human Immunodeficiency Virus (HIV) positive.
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- Subjects with severe hepatic deficiencies.
- Subjects with a glycated hemoglobin A1c (HbA1c) level of > 12%.
- Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
- Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.
- Subjects who are currently receiving dialysis.
- Subjects who are pregnant or breast-feeding.
- Subjects who are unwilling to use an "effective" method of contraception during the study.
- Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site.
- Subjects who have a clinically relevant history of alcohol or drugs abuse.
- Subject's blood sugar is > 450 mg/dL at postprandial.
- Subjects who are not able to understand the objective of this study or to comply with the study requirements.
- Subjects who are considered to have a significant disease which can impact the study by the investigator.
- Subjects who are considered not suitable for the study by the investigator.
- Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma site).
- Subjects who are currently or were enrolled in another clinical study within 60 days of screening.
- Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
- Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers
This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a diabetic foot ulcer.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- ALLO-ASC-DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALLO-ASC-DFUBiological
| Study group | Role | What they receive |
|---|---|---|
| ALLO-ASC-DFU | Experimental | ALLO-ASC-DFU treatment with conventional care Receives: Biological: ALLO-ASC-DFU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to 4 weeks
Secondary outcomes (1)
Wound size and depth measurement
Evaluation of the improvement of wound measured by size and depth, and examines the change for 4 weeks period.
Measured: baseline and 1, 2, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionJul 2015
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.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joon Pio Hong, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394886
- Sponsor's protocol ID
- ALLO-ASC-DFU-101
- Status last verified
- Mar 2015
- First submitted
- 3 Mar 2015
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT02394886
- Acronym / sponsor ID
- ALLO-ASC-DFU-101
- Conditions
- Diabetic Foot Ulcer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Mar 2015 (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.
This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a diabetic foot ulcer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALLO-ASC-DFU | Experimental | Biological: ALLO-ASC-DFUALLO-ASC-DFU treatment with conventional care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is between 18 and 80 years of age.
- Subject is diagnosed with Type I or Type II diabetes.
- Subjects who have a wound defined as diabetic foot ulcer presence for more than 4 weeks, but not present for more than 54 weeks at the screening visit.
- Foot ulcer located below the malleoli on plantar or dorsal surface of the foot and ulcer size is between 1 cm^2 and 25 cm^2.
- Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
Key exclusion criteria (23 listed)
- Ulcer is of non-diabetic pathophysiology.
- Gangrene is present on any part of the affected foot.
- Ulcer is over an active Charcot deformity.
- The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
- The longest dimension of the Index Ulcer exceeds 5 cm at the screening visit.
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 |
|---|---|---|
| ALLO-ASC-DFU | Biological | ALLO-ASC-DFU |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 4 weeks
1 secondary outcome
Wound size and depth measurement
Time frame: baseline and 1, 2, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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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.
Joon Pio Hong, MD, PhD principal investigator
Asan Medical Center
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 ALLO-ASC-DFU in people with Diabetic Foot Ulcer, run by Anterogen Co., Ltd. at 1 site in South Korea.
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 8 inclusion and 23 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: finished, as of the sponsor's last update on 16 Oct 2015. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: up to 4 weeks). 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 16 Oct 2015.