Critical Leg IschemiaPhase 1NCT00377897
Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)
A Phase 1 study testing cell therapy in people with Critical Leg Ischemia, run by University of Paris 5 - Rene Descartes at 1 site in France.
Trial summary
This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Leg Ischemia
- What is being tested?
- cell therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Signature of informed consent
- Critical leg ischemia with ankle pressure < 70 mmHg
- Ischemic ulcer or gangrene
- No possibility of surgical revascularization
- No possibility of angioplasty
Who cannot join
- Cancer
- Suspicion of a cancer on X-Ray, mammography or elevated PSA
- Age < 18
- Life expectancy < 6 months
- Active retinopathy
- Angioplasty or surgical revascularization within 3 months
- Stoke within 3 months
- HIV + or HCV/HBC+
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose
This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).
Read the detailed description
Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.
Patients will then be followed-up every week during one month and then every month during one year.
This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).
It began including patients in January 2005 and will last until December 2007.
- Conditions
- Critical Leg Ischemia
- Being tested
- cell therapy
- Keywords
- critical leg ischemia, PAD, cell therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell therapyProcedure or surgery
Injection of Bone-Marrow mononuclear cells in the muscles of the calf.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle brachial index
Measured: 6 months
Healing
Measured: 1 year
Amputation rate
Measured: 1 year
Secondary outcomes (1)
TcPO2
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 posted19 Sep 2006 (estimated)
- Study startJan 2005
- Primary completionSep 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Critical Leg IschemiaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Investigators
- Joseph Emmerich, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377897
- Sponsor's protocol ID
- OPTIPEC
- Status last verified
- Feb 2009
- First submitted
- 18 Sep 2006
- Last updated
- 16 Feb 2009
- Results posted
- No
Publications
Oubari H, Labreuche J, Reytier C, Dignat-George F, Duong-Van-Huyen JP, Emmerich J, Gaussem P, Bruneval P, Blot-Chabaud M, Lellouch AG, Bardin N, Smadja DM. Soluble CD146 reflects altered endothelial and metabolic homeostasis in peripheral artery disease. Angiogenesis. 2026 Jun 9;29(3):41. doi: 10.1007/s10456-026-10064-6.
PubMed 42265522HoWangYin KY, Loinard C, Bakker W, Guerin CL, Vilar J, d'Audigier C, Mauge L, Bruneval P, Emmerich J, Levy BI, Pouyssegur J, Smadja DM, Silvestre JS. HIF-prolyl hydroxylase 2 inhibition enhances the efficiency of mesenchymal stem cell-based therapies for the treatment of critical limb ischemia. Stem Cells. 2014 Jan;32(1):231-43. doi: 10.1002/stem.1540.
PubMed 24105925Smadja DM, Duong-van-Huyen JP, Dal Cortivo L, Blanchard A, Bruneval P, Emmerich J, Gaussem P. Early endothelial progenitor cells in bone marrow are a biomarker of cell therapy success in patients with critical limb ischemia. Cytotherapy. 2012 Feb;14(2):232-9. doi: 10.3109/14653249.2011.627917. Epub 2011 Oct 31.
PubMed 22040109Smadja DM, d'Audigier C, Guerin CL, Mauge L, Dizier B, Silvestre JS, Dal Cortivo L, Gaussem P, Emmerich J. Angiogenic potential of BM MSCs derived from patients with critical leg ischemia. Bone Marrow Transplant. 2012 Jul;47(7):997-1000. doi: 10.1038/bmt.2011.196. Epub 2011 Oct 10. No abstract available.
PubMed 21986637Smadja DM, d'Audigier C, Bieche I, Evrard S, Mauge L, Dias JV, Labreuche J, Laurendeau I, Marsac B, Dizier B, Wagner-Ballon O, Boisson-Vidal C, Morandi V, Duong-Van-Huyen JP, Bruneval P, Dignat-George F, Emmerich J, Gaussem P. Thrombospondin-1 is a plasmatic marker of peripheral arterial disease that modulates endothelial progenitor cell angiogenic properties. Arterioscler Thromb Vasc Biol. 2011 Mar;31(3):551-9. doi: 10.1161/ATVBAHA.110.220624. Epub 2010 Dec 9.
PubMed 21148423
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose
- ClinicalTrials.gov ID
- NCT00377897
- Acronym / sponsor ID
- OPTIPEC
- Conditions
- Critical Leg Ischemia
- Keywords
- critical leg ischemia, PAD, cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- Jan 2005
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Sep 2006 (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 study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).
Detailed description
Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.
Patients will then be followed-up every week during one month and then every month during one year.
This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).
It began including patients in January 2005 and will last until December 2007.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18
- Signature of informed consent
- Critical leg ischemia with ankle pressure < 70 mmHg
- Ischemic ulcer or gangrene
- No possibility of surgical revascularization
Key exclusion criteria (8 listed)
- Cancer
- Suspicion of a cancer on X-Ray, mammography or elevated PSA
- Age < 18
- Life expectancy < 6 months
- Active retinopathy
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 |
|---|---|---|
| cell therapyInjection of Bone-Marrow mononuclear cells in the muscles of the calf. | Procedure or surgery | – |
Primary outcome
Ankle brachial index
Time frame: 6 months
Healing
Time frame: 1 year
Amputation rate
Time frame: 1 year
1 secondary outcome
TcPO2
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 16 Feb 2009.
- Derived from this study: PubMed 42265522Oubari H, Labreuche J, Reytier C, Dignat-George F, Duong-Van-Huyen JP, Emmerich J, Gaussem P, Bruneval P, Blot-Chabaud M, Lellouch AG, Bardin N, Smadja DM. Soluble CD146 reflects altered endothelial and metabolic homeostasis in peripheral artery disease. Angiogenesis. 2026 Jun 9;29(3):41. doi: 10.1007/s10456-026-10064-6.
- Derived from this study: PubMed 24105925HoWangYin KY, Loinard C, Bakker W, Guerin CL, Vilar J, d'Audigier C, Mauge L, Bruneval P, Emmerich J, Levy BI, Pouyssegur J, Smadja DM, Silvestre JS. HIF-prolyl hydroxylase 2 inhibition enhances the efficiency of mesenchymal stem cell-based therapies for the treatment of critical limb ischemia. Stem Cells. 2014 Jan;32(1):231-43. doi: 10.1002/stem.1540.
- Derived from this study: PubMed 22040109Smadja DM, Duong-van-Huyen JP, Dal Cortivo L, Blanchard A, Bruneval P, Emmerich J, Gaussem P. Early endothelial progenitor cells in bone marrow are a biomarker of cell therapy success in patients with critical limb ischemia. Cytotherapy. 2012 Feb;14(2):232-9. doi: 10.3109/14653249.2011.627917. Epub 2011 Oct 31.
- Derived from this study: PubMed 21986637Smadja DM, d'Audigier C, Guerin CL, Mauge L, Dizier B, Silvestre JS, Dal Cortivo L, Gaussem P, Emmerich J. Angiogenic potential of BM MSCs derived from patients with critical leg ischemia. Bone Marrow Transplant. 2012 Jul;47(7):997-1000. doi: 10.1038/bmt.2011.196. Epub 2011 Oct 10. No abstract available.
- Derived from this study: PubMed 21148423Smadja DM, d'Audigier C, Bieche I, Evrard S, Mauge L, Dias JV, Labreuche J, Laurendeau I, Marsac B, Dizier B, Wagner-Ballon O, Boisson-Vidal C, Morandi V, Duong-Van-Huyen JP, Bruneval P, Dignat-George F, Emmerich J, Gaussem P. Thrombospondin-1 is a plasmatic marker of peripheral arterial disease that modulates endothelial progenitor cell angiogenic properties. Arterioscler Thromb Vasc Biol. 2011 Mar;31(3):551-9. doi: 10.1161/ATVBAHA.110.220624. Epub 2010 Dec 9.
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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.
Joseph Emmerich principal investigator
Assistance Publique - Hôpitaux de Paris
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 cell therapy in people with Critical Leg Ischemia, run by University of Paris 5 - Rene Descartes at 1 site in France.
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 6 inclusion and 8 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 16 Feb 2009. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph Emmerich, MD, PhD (33 1 56 09 30 51, joseph.emmerich@egp.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle brachial index (time frame: 6 months). The study lists 3 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 NCT00377897, which also lists 5 linked publications.
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 Feb 2009.