Diabetic Foot UlcerPhase 1REDDSTARNCT03509870
Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells to Non-healing Diabetic Foot Wounds
A Phase 1 study testing mesenchymal stromal cells in people with Diabetic Foot Ulcer, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers 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?
- mesenchymal stromal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2018to 1 Apr 2020
- 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
- Age 18-80 years.
- Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease).
- HbA1c ≤ 97 mmol/mol (≤ 11%).
- Males or non-pregnant females.
- Understand trial information document.
- Provide written informed consent.
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- Duration of (diabetic foot) wound > 4 but < 52 weeks.
- Reduction of < 50% area over 4 weeks despite standard care (standard care; off-loading, weekly debridement, dressings, orthotic).
- Wound area with sharp debridement of ≥ 0.5 but ≤ 4.0 cm2.
- Clinically non-infected wound.
- Texas wound stage 1a, 1c or 2a.
- Location of wound below malleolus.
- Affected limb toe pressure ≥ 40 mmHg.
- An ankle-brachial systolic pressure index between 0.7 and 1.3.
- Diagnosis of peripheral neuropathy using American Diabetes Association guidelines (monofilament/vibration sensation/biothesiometer).
- Able to adhere to study visit protocol.
- Adhere to offloading devices/orthotic.
Who cannot join
- Life expectancy of less than 12 months.
- Patients with a definite diagnosis of any immunodeficiency disorder.
- Viral hepatitis [patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)].
- Active, uncontrolled connective tissue disease.
- Renal failure as defined by serum creatinine > 220 µmol/L.
- Liver function tests that are > 2.0 times Upper Limit Normal.
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- Poor nutritional status as measured by serum albumin < 30 g/L.
- Active cancer or a history of cancer in the 5 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).
- Active wound infection (i.e. recent onset of erythema, oedema, and increased temperature of the foot with normal radiographs).
- Diabetic Charcot neuroarthropathy or other structural deformity that would prevent adequate off-loading of the study foot.
- Treatment with any systemic corticosteroid immunosuppressive chemotherapeutic agent, antiviral, or previous/current radiation therapy to lower extremity to be treated within 30 days prior to signing the informed consent form.
- Having received another investigational drug or biologic within 30 days prior to signing the informed consent form or currently participating in an investigational drug or biologic study.
- A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance.
- History of non-compliance with treatment or clinical visit attendance (i.e. this study requires that patients will comply with the protocol and ulcer care regimen).
- Any unstable medical condition judged by the Principal Investigator that would cause the study to be detrimental to the patient.
- Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.
- Wounds with an aetiology not related to diabetes.
- More than three wounds on the target lower extremity.
- The wound to be studied not anatomically distinct from another wound(s) (separated by < 1 cm from another wound or would interfere with standard of care treatment of another wound. Only one single wound per one study subject can be treated in this study.
- Wounds which decrease in area by > 50% during the screening 4-week run-in period.
- Ulcers with underlying osteomyelitis on the leg with the wound to be treated.
- Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).
- Revascularization surgery on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
- Surgery to lengthen Achilles tendon on the leg with the wound to be treated ≤8 weeks prior to signing the informed consent form.
- Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.
- Received dermal substitute or living skin equivalent within 30 days prior to signing the informed consent form.
- Received prior (Regranex®/becaplermin) therapy within 30 days prior to signing the informed consent form.
- Has known history of clinical sensitivity reactions to products of bovine origin or to the primary or secondary dressings used in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncontrolled Non-randomised Single Dose Study of Topically Applied Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells (REDDSTAR (ORBCEL-M)) in Patients With Non-healing Neuroischaemic Diabetic Foot Wounds'
examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers
Read the detailed description
1.1 Trial Phase
Phase 1b
1.2 Trial Aims and Objectives
To examine the safety of topical application of a single dose of allogeneic bone marrow derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.
1.3 Patient Population
Patients with non-healing neuroischaemic diabetic foot wounds despite standard care.
1.4 Trial Setting
Steno Diabetes Center Copenhagen, Denmark and Zelo Phase I Unit, Bispebjerg Hospital, Copenhagen, Denmark.
1.5 Trial Intervention
Topical application of allogeneic bone marrow derived mesenchymal stromal cells seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.
1.6 Concurrent Control
Open label, uncontrolled, non-randomised, single dose study.
1.7 Sample Size
9
1.8 Method of Participant Assignment
Administration of a single dose of allogeneic bone marrow-derived mesenchymal stromal cells seeded in a collagen scaffold.
1.9 Examination Points
0, 1 week, 2 weeks, 3 weeks, 4 weeks up until 12 weeks or until complete wound closure. After the week 12 visit, or ulcer closure, whichever occurs first, each patient will return to the clinic 1 (± 2 days), 2 (± 2 days), 4 (± 3 days), 8 (±3 days), and 12 (±3days) weeks later for follow-up visits to for adverse events, assess wound, wound closure and durability.
1.10 Primary Outcome
Serious adverse events that are attributable to intervention.
1.11 Secondary Outcomes
Time to complete wound closure (defined as from treatment day 1 to the first visit when closure is documented). Absolute and percent changes in wound area from baseline, at weekly intervals throughout. Durability of wound closure as measured at 4 week intervals for 12 weeks from date of wound closure.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- mesenchymal stromal cells
- Keywords
- diabetes
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesenchymal stromal cellsBiological
mesenchymal stromal cells in a collagen scaffold
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stromal cells | Other | mesenchymal stromal cells in collagen scaffold Receives: Biological: mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
serious adverse events attributable to intervention
- Death
- Septicaemia
- Amputation of the limb administered with therapy
- Worsening of the ulcer of the limb administered with therapy
- Allergic reaction or anaphylaxis
- Abnormal laboratory results
- Local or systemic reaction requiring hospital admission
Measured: 24 weeks
Secondary outcomes (1)
healing
time to complete wound closure
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Jun 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: study stopped because of lack of recruitment
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
- Model description
- unblinded single arm intervention
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter Rossing, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509870
- Sponsor's protocol ID
- 2015-005580-16
- Other IDs
- 2015
- Acronym
- REDDSTAR
- Status last verified
- Aug 2020
- First submitted
- 11 Apr 2018
- Last updated
- 19 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Non-randomised Single Dose Study of Topically Applied Bone Marrow Derived Allogeneic Mesenchymal Stromal Cells (REDDSTAR (ORBCEL-M)) in Patients With Non-healing Neuroischaemic Diabetic Foot Wounds'
- ClinicalTrials.gov ID
- NCT03509870
- Acronym / sponsor ID
- REDDSTAR / 2015-005580-16
- Conditions
- Diabetic Foot Ulcer
- Keywords
- diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study stopped because of lack of recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 26 Apr 2018 (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.
examine safety of topical application of single dose allogeneic bone marrow derived mesenchymal stromal cells to non-healing diabetic foot ulcers
Detailed description
1.1 Trial Phase
Phase 1b
1.2 Trial Aims and Objectives
To examine the safety of topical application of a single dose of allogeneic bone marrow derived mesenchymal stromal cells (REDDSTAR ORBCEL-M) seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.
1.3 Patient Population
Patients with non-healing neuroischaemic diabetic foot wounds despite standard care.
1.4 Trial Setting
Steno Diabetes Center Copenhagen, Denmark and Zelo Phase I Unit, Bispebjerg Hospital, Copenhagen, Denmark.
1.5 Trial Intervention
Topical application of allogeneic bone marrow derived mesenchymal stromal cells seeded in a collagen scaffold to patients with non-healing neuroischaemic diabetic foot wounds.
1.6 Concurrent Control
Open label, uncontrolled, non-randomised, single dose study.
1.7 Sample Size
9
1.8 Method of Participant Assignment
Administration of a single dose of allogeneic bone marrow-derived mesenchymal stromal cells seeded in a collagen scaffold.
1.9 Examination Points
0, 1 week, 2 weeks, 3 weeks, 4 weeks up until 12 weeks or until complete wound closure. After the week 12 visit, or ulcer closure, whichever occurs first, each patient will return to the clinic 1 (± 2 days), 2 (± 2 days), 4 (± 3 days), 8 (±3 days), and 12 (±3days) weeks later for follow-up visits to for adverse events, assess wound, wound closure and durability.
1.10 Primary Outcome
Serious adverse events that are attributable to intervention.
1.11 Secondary Outcomes
Time to complete wound closure (defined as from treatment day 1 to the first visit when closure is documented). Absolute and percent changes in wound area from baseline, at weekly intervals throughout. Durability of wound closure as measured at 4 week intervals for 12 weeks from date of wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- unblinded single arm intervention
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stromal cells | Other | Biological: mesenchymal stromal cellsmesenchymal stromal cells in collagen scaffold |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18-80 years.
- Type 1 or Type 2 diabetes mellitus (with any kind or combination of pharmacological treatment for disease and/or complications to disease).
- HbA1c ≤ 97 mmol/mol (≤ 11%).
- Males or non-pregnant females.
- Understand trial information document.
Key exclusion criteria (28 listed)
- Life expectancy of less than 12 months.
- Patients with a definite diagnosis of any immunodeficiency disorder.
- Viral hepatitis [patient must have negative hepatitis B surface-antigen (HBsAg) and hepatitis C antibody (HepCAb) test results obtained within 2 weeks prior to the Treatment Day (Day 1)].
- Active, uncontrolled connective tissue disease.
- Renal failure as defined by serum creatinine > 220 µmol/L.
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 stromal cellsmesenchymal stromal cells in a collagen scaffold | Biological | mesenchymal stromal cells |
Primary outcome
serious adverse events attributable to intervention
Time frame: 24 weeks
1. Death 2. Septicaemia 3. Amputation of the limb administered with therapy 4. Worsening of the ulcer of the limb administered with therapy 5. Allergic reaction or anaphylaxis 6. Abnormal laboratory results 7. Local or systemic reaction requiring hospital admission
1 secondary outcome
healing
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: study stopped because of lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
- Individual participant dataSharing planned: Undecided
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
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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.
Peter Rossing, MD principal investigator
Steno Diabetes Center Copenhagen
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 stromal cells in people with Diabetic Foot Ulcer, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 17 inclusion and 28 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: stopped early, as of the sponsor's last update on 19 Aug 2020. 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 Denmark. 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 was stopped early (reason given: study stopped because of lack of recruitment). Results are not available in the source record.
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?
serious adverse events attributable to intervention (time frame: 24 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 19 Aug 2020.