Peripheral Vascular DiseasesPhase 3BALINCT00904501
Bone Marrow Autograft in Limb Ischemia
A Phase 3 study testing Bone marrow harvest in people with Peripheral Vascular Diseases, run by CHU de Reims at 15 sites in France.
Trial summary
BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option. The main end point is the survival without major amputation 6 months after implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Bone marrow harvest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 15 sitesFrance
- Study dates
- Mar 2009to Jan 2015
- Phase
- Phase 3
- 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
- Critical limb ischemia
- No possible surgical treatment
Who cannot join
- Ongoing infectious disease
- Gangrene extending beyond the digits
- Diabetes mellitus with HbA1c > 7.5% or with proliferative retinopathy
- History of malignant disease
- Contra-indication to general anaesthesia
- Chronic haemodialysis
Show all 11Show fewer
- Prothrombin Time < 50%
- Recent onset (within 3 months) of myocardial infarction or brain infarction
- Contra-indication to modification of anti-platelet or anticoagulant therapy
- History of heparin-induced thrombocytopenia
- Unexplained haematological abnormality
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
CHU
Amiens, 80054
CHU
Besançon, 25030
CHU
Bordeaux, 33075
CHU
Bordeaux, 33604
CHU
Caen, 14033
CHU
Grenoble, 38043
CHU
Lille, 59037
CHU
Limoges, 87000
CHU
Marseille, 13005
Centre Hospitalier
Mulhouse, 68100
CHU
Nancy, 54511
CHU
Nantes, 44035
HEGP
Paris, 75908
Chu Reims
Reims, 51092
Chu Strasbourg
Strasbourg, 67091
About this study
Official title: Cell Therapy in Critical Limb Ischemia
BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option.
The main end point is the survival without major amputation 6 months after implantation.
Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their angiogenic properties.
Read the detailed description
One hundred and ten patients with critical leg ischemia and no surgical option will be included. A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30 mL) for all included patients. For half of them, the BM-MNC are implanted on the same day whereas the others are implanted with a placebo cell-product (30 mL saline with 4 ml peripheral blood). For these patients the BM-MNC are cryo-conserved. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted. The main end point is the survival without major amputation 6 months after implantation. After this delay it is possible to use previously cryo-conserved BM-MNC. Likewise biological studies are performed on BM-MNC: flow-cytometry analysis of progenitor cells content, proteins and mRNAs expression, induced angiogenesis in animal models.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Bone marrow harvest
- Keywords
- Limb ischemia, Cell Therapy
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow harvestProcedure or surgery
Implantation of placebo
Bone marrow harvestProcedure or surgery
Implantation of bone marrow - mononuclear cells
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30mL). A placebo cell-product (30 mL saline with 4 ml peripheral blood) is implanted and the BM-MNC are cryo-conserved. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted. After 6 months, it is possible to use previously cryo-conserved BM-MNC. Receives: Procedure: Bone marrow harvest |
| B | Experimental | A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30mL) . The BM-MNC are implanted on the same day. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted Receives: Procedure: Bone marrow harvest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major amputation rate and mortality
Measured: 6 months
Secondary outcomes (1)
Clinical symptoms and haemodynamical parameters
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 May 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Collaborators
- Etablissement Français du Sang
- Responsible party
- Principal investigator, PIGNON, CHU de Reims
- Investigators
- Bernard PIGNON, Study director, CHU REIMS FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904501
- Sponsor's protocol ID
- PHRC2007- N11-02
- Acronym
- BALI
- Status last verified
- Mar 2016
- First submitted
- 18 May 2009
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell Therapy in Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT00904501
- Acronym / sponsor ID
- BALI / PHRC2007- N11-02
- Conditions
- Peripheral Vascular Diseases
- Keywords
- Limb ischemia, Cell Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Collaborators
- Etablissement Français du Sang
- Study start
- Mar 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 19 May 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.
BALI (Bone marrow Autograft in Limb Ischemia) is a randomized double-blind trial comparing implantation of bone marrow - mononuclear cells versus placebo in patients presenting with critical leg ischemia and no surgical option.
The main end point is the survival without major amputation 6 months after implantation.
Biological studies are performed on bone marrow mononuclear cells (BM-MNC) to evaluate their angiogenic properties.
Detailed description
One hundred and ten patients with critical leg ischemia and no surgical option will be included. A bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30 mL) for all included patients. For half of them, the BM-MNC are implanted on the same day whereas the others are implanted with a placebo cell-product (30 mL saline with 4 ml peripheral blood). For these patients the BM-MNC are cryo-conserved. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted. The main end point is the survival without major amputation 6 months after implantation. After this delay it is possible to use previously cryo-conserved BM-MNC. Likewise biological studies are performed on BM-MNC: flow-cytometry analysis of progenitor cells content, proteins and mRNAs expression, induced angiogenesis in animal models.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Procedure: Bone marrow harvestA bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30mL). A placebo cell-product (30 mL saline with 4 ml peripheral blood) is implanted and the BM-MNC are cryo-conserved. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted. After 6 months, it is possible to use previously cryo-conserved BM-MNC. |
| B | Experimental | Procedure: Bone marrow harvestA bone marrow harvest (500 mL under general anaesthesia) is performed and BM-MNC are separated and concentrated (30mL) . The BM-MNC are implanted on the same day. Only the cell therapy unit, neither the patient, nor the clinician, know whether BM-MNC or placebo is implanted |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critical limb ischemia
- No possible surgical treatment
Key exclusion criteria (11 listed)
- Ongoing infectious disease
- Gangrene extending beyond the digits
- Diabetes mellitus with HbA1c > 7.5% or with proliferative retinopathy
- History of malignant disease
- Contra-indication to general anaesthesia
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 |
|---|---|---|
| Bone marrow harvestImplantation of placebo | Procedure or surgery | A |
| Bone marrow harvestImplantation of bone marrow - mononuclear cells | Procedure or surgery | B |
Primary outcome
Major amputation rate and mortality
Time frame: 6 months
1 secondary outcome
Clinical symptoms and haemodynamical parameters
Time frame: 6 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 8 Mar 2016.
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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.
Bernard PIGNON study director
CHU REIMS FRANCE
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone marrow harvest in people with Peripheral Vascular Diseases, run by CHU de Reims at 15 sites 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 2 inclusion and 11 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 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Major amputation rate and mortality (time frame: 6 months). 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 8 Mar 2016.