Chronic Leg UlcerPhase 1NCT02619734
Autologous Bone Marrow Stem Cells for Chronic Leg Ulcer Treatment in Sickle Cell Disease
A Phase 1 study testing Infusion of Autologous Bone Marrow Mononuclear Cells in people with Chronic Leg Ulcer and Sickle Cell Disease, run by Federal University of Bahia.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Leg Ulcer, Sickle Cell Disease
- What is being tested?
- Infusion of Autologous Bone Marrow Mononuclear Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Aug 2016
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stable sickle cell disease patients
- Patient hospitalized into the dermatology unit
- Patient with an evolutive leg ulcer since more than 1 year
- No infection at the time of surgery
- Patient competent to give informed consent
Who cannot join
- Patients with a history of corticosteroids or on active therapy
- infection at the limb affected by ulcer
- Recurrent painful crises,
- Immunosuppressive drug therapy,
- Pregnancy,
- Presence of neoplastic disease or any other clinical concurrent condition other than sickle cell disease that predisposed them to the development of leg ulcer
About this study
Official title: Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.
Read the detailed description
Implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing.
In the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. Forty cases will be enrolled. Improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.
- Conditions
- Chronic Leg Ulcer, Sickle Cell Disease
- Being tested
- Infusion of Autologous Bone Marrow Mononuclear Cells
- Keywords
- Cell Therapy, Sickle cell disease, Autologous implantation, Mesenchymal stromal cell, Edothelial Progenitor cell
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of Autologous Bone Marrow Mononuclear CellsBiological
Autologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers |
| Stem Cell Injection | Experimental | Intramuscular implantation of Autologous bone marrow-derived mononuclear cells Receives: Biological: Infusion of Autologous Bone Marrow Mononuclear Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Measured: 6 months
Change in Leg Ulcer
Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded
Measured: 6 months to one year
Secondary outcomes (3)
Numeric pain intensity scale (0-10)
Change in Sickle Cell Disease leg ulcer wound pain scores as measured by a 10-point scale (analogic visual scale) and relative to non-wound site pain scores
Measured: 6 months to one year
Ulcer Healing
Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area Ulcer diameter will be recorded
Measured: 6 months to one year
Quality of Life
Change in quality of life as well as other indicators of patient comfort and well-being
Measured: 6 months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startAug 2006
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Leg 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Responsible party
- Principal investigator, Vitor Fortuna, Federal University of Bahia
- Investigators
- José Valber Meneses, MD, Study chair, Federal University of BahiaGildasio Daltro, MD, Study director, Federal University of BahiaVitor A Fortuna, PhD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619734
- Sponsor's protocol ID
- 11738
- Status last verified
- Nov 2015
- First submitted
- 30 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Daltro GC, Fortuna V, de Souza ES, Salles MM, Carreira AC, Meyer R, Freire SM, Borojevic R. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015 May 29;6(1):110. doi: 10.1186/s13287-015-0105-2.
PubMed 26021713
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Autologous Bone Marrow Stem Cells Infusion for Treatment of Chronic Leg Ulcer in Sickle Cell Disease Patients
- ClinicalTrials.gov ID
- NCT02619734
- Acronym / sponsor ID
- 11738
- Conditions
- Chronic Leg Ulcer, Sickle Cell Disease
- Keywords
- Cell Therapy, Sickle cell disease, Autologous implantation, Mesenchymal stromal cell, Edothelial Progenitor cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Collaborators
- Oswaldo Cruz Foundation
- Study start
- Aug 2006
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 2 Dec 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.
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow stem cell implantation for the treatment of leg ulcer in adult patients with sickle cell disease.
Detailed description
Implantation of bone marrow mononuclear cells, including endothelial progenitor cells and mesenchymal stromal cells, into leg ulcers has been shown to improve wound healing.
In the present study the safety and efficacy of autologous bone marrow mononuclear cells implantation will be investigated in patients with chronic leg ulcers. Forty cases will be enrolled. Improvement in the pain, rate and extent of leg ulcer wound healing as measured by change in wound surface area will be evaluated until one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Conventional treatment established by the good clinical practice Patients received standard local care dressing method (compresses) to heal leg ulcers |
| Stem Cell Injection | Experimental | Biological: Infusion of Autologous Bone Marrow Mononuclear CellsIntramuscular implantation of Autologous bone marrow-derived mononuclear cells |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Stable sickle cell disease patients
- Patient hospitalized into the dermatology unit
- Patient with an evolutive leg ulcer since more than 1 year
- No infection at the time of surgery
- Patient competent to give informed consent
Key exclusion criteria (6 listed)
- Patients with a history of corticosteroids or on active therapy
- infection at the limb affected by ulcer
- Recurrent painful crises,
- Immunosuppressive drug therapy,
- Pregnancy,
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 |
|---|---|---|
| Infusion of Autologous Bone Marrow Mononuclear CellsAutologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1. | Biological | Stem Cell Injection |
Primary outcome
Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Time frame: 6 months
Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events
Change in Leg Ulcer
Time frame: 6 months to one year
Rate and extent of leg ulcer wound healing as measured by change in wound surface area Ulcer diameter will be recorded
3 secondary outcomes
Numeric pain intensity scale (0-10)
Time frame: 6 months to one year
Ulcer Healing
Time frame: 6 months to one year
Quality of Life
Time frame: 6 months to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 26021713Daltro GC, Fortuna V, de Souza ES, Salles MM, Carreira AC, Meyer R, Freire SM, Borojevic R. Efficacy of autologous stem cell-based therapy for osteonecrosis of the femoral head in sickle cell disease: a five-year follow-up study. Stem Cell Res Ther. 2015 May 29;6(1):110. doi: 10.1186/s13287-015-0105-2.
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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.
José Valber Meneses, MD study chair
Federal University of Bahia
Gildasio Daltro, MD study director
Federal University of Bahia
Vitor A Fortuna, PhD principal investigator
Federal University of Bahia
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infusion of Autologous Bone Marrow Mononuclear Cells in people with Chronic Leg Ulcer and Sickle Cell Disease, run by Federal University of Bahia.
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 5 inclusion and 6 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 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Safety of Treatment - Determined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, and reported adverse events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619734, which also lists 1 linked publication.
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 2015.