Peripheral Vascular DiseasesPhase 1/2NCT00872326
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
A Phase 1/2 study testing Autologous Bone Marrow Mononuclear Cells in people with Peripheral Vascular Diseases and Diabetic Foot, run by Andalusian Network for Design and Translation of Advanced Therapies at 1 site in Spain.
Trial summary
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Vascular Diseases, Diabetic Foot
- What is being tested?
- Autologous Bone Marrow Mononuclear Cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2007to May 2009
- 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
- Diabetic patients under treatment (type I or II)
- Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index < 0,8)
- Not suitable to be revascularized (surgical and interventional consensus)
Who cannot join
- Neoplastic disease and/or hematologic disease during the last 2 years
- Diabetic retinopathy
- Ischemic ulcer greater than 10 cm2
- Major amputation at target limb
- Life expectancy > 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Read the detailed description
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease.
After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes.
Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of:
- Changes in below-the-knee angiography from baseline to 3 months follow-up.
- Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.
- Conditions
- Peripheral Vascular Diseases, Diabetic Foot
- Being tested
- Autologous Bone Marrow Mononuclear Cells
- Keywords
- Diabetes Complications, Lower limb ischemia, Adult stem cells
- Medical subject headings
- Peripheral Vascular Diseases, Diabetic Foot, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Bone Marrow Mononuclear CellsProcedure or surgery
Infusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Bone Marrow Mononuclear Cells | Experimental | Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells Receives: Procedure: Autologous Bone Marrow Mononuclear Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic evaluation of angiogenesis and vasculogenesis at target limb
Measured: 3 months
Secondary outcomes (1)
Ankle-Brachial pressure index
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 posted31 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionMay 2009
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 Peripheral Vascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Antonio de la Cuesta, MD, Principal investigator, Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San LazaroManuel Constantino, PhD, Principal investigator, Chief of Hematology. Hospital Universitario Virgen MacarenaRafael J Ruiz-Salmeron, PhD, Principal investigator, Chief of Endovascular Unit. Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872326
- Sponsor's protocol ID
- C/ICPD/2007
- Other IDs
- FPS C/ICPD/2007
- Status last verified
- Nov 2014
- First submitted
- 30 Mar 2009
- Last updated
- 14 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Perez-Camacho I, Marcos-Sanchez F, Hmadcha A, Soria B. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011;20(10):1629-39. doi: 10.3727/096368910X0177.
PubMed 22289660
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00872326
- Acronym / sponsor ID
- C/ICPD/2007
- Conditions
- Peripheral Vascular Diseases, Diabetic Foot
- Keywords
- Diabetes Complications, Lower limb ischemia, Adult stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced TherapiesUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 31 Mar 2009 (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 aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Detailed description
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease.
After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes.
Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of:
- Changes in below-the-knee angiography from baseline to 3 months follow-up.
- Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Bone Marrow Mononuclear Cells | Experimental | Procedure: Autologous Bone Marrow Mononuclear CellsConsecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diabetic patients under treatment (type I or II)
- Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index < 0,8)
- Not suitable to be revascularized (surgical and interventional consensus)
Key exclusion criteria (5 listed)
- Neoplastic disease and/or hematologic disease during the last 2 years
- Diabetic retinopathy
- Ischemic ulcer greater than 10 cm2
- Major amputation at target limb
- Life expectancy > 2 years
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 |
|---|---|---|
| Autologous Bone Marrow Mononuclear CellsInfusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow. | Procedure or surgery | Autologous Bone Marrow Mononuclear Cells |
Primary outcome
Angiographic evaluation of angiogenesis and vasculogenesis at target limb
Time frame: 3 months
1 secondary outcome
Ankle-Brachial pressure index
Time frame: 3 months
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 14 Nov 2014.
- Derived from this study: PubMed 22289660Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Perez-Camacho I, Marcos-Sanchez F, Hmadcha A, Soria B. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011;20(10):1629-39. doi: 10.3727/096368910X0177.
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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.
Antonio de la Cuesta, MD principal investigator
Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro
Manuel Constantino, PhD principal investigator
Chief of Hematology. Hospital Universitario Virgen Macarena
Rafael J Ruiz-Salmeron, PhD principal investigator
Chief of Endovascular Unit. Hospital Universitario Virgen Macarena
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 Autologous Bone Marrow Mononuclear Cells in people with Peripheral Vascular Diseases and Diabetic Foot, run by Andalusian Network for Design and Translation of Advanced Therapies at 1 site in Spain.
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 3 inclusion and 5 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 14 Nov 2014. 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 Spain. 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?
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?
Angiographic evaluation of angiogenesis and vasculogenesis at target limb (time frame: 3 months). 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 NCT00872326, 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 14 Nov 2014.