Peripheral Vascular DiseasesPhase 1/2ACELLDREAMNCT01211028
Adipose CELL Derived Regenerative Endothelial Angiogenic Medicine
A Phase 1/2 study testing Expanded autologous ASCs in people with Peripheral Vascular Diseases and Cardiovascular Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Cardiovascular Diseases
- What is being tested?
- Expanded autologous ASCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Jul 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe peripheral vascular disease not amenable to bypass or angioplasty
- Age >40 years old
- Normal renal function (creatinine < 1.6)
- Non pregnant female
- Lifespan > 6 months
Who cannot join
- Age <40 years old
- Refusal to give informed consent and/orCognitively disabled
- Congestive heart failure or stroke in the last 3 months
- History of cancer or myeloproliferative disorders
- Proliferative retinopathy
- Pregnancy
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- Positive screening test for HIV, Hepatitis B or Hepatitis C
- Buerger patient
- Cachexia or predicted impossibility for a biopsy of at least 30 grams of fat tissue
- Pregnancy or lactation
- Having been non controlled severe pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.
- Being tested
- Expanded autologous ASCs
- Keywords
- Critical leg ischemia, Adipose derived Stroma/Stem Cells, Autologous, Angiogenesis
- Medical subject headings
- Peripheral Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expanded autologous ASCsBiological
Also called Expanded autologous Adipose-derived adult Stroma/Stem cells
Drug: Expanded autologous adipose-derived adult stroma/stem cells
| Study group | Role | What they receive |
|---|---|---|
| Autologous ASCs | Other | Expanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells. Receives: Biological: Expanded autologous ASCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Nature of Adverse Events : safety and tolerability
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ]
Measured: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJan 2009
- Primary completionJul 2012
- Study completionJul 2012
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- French Blood Establishment, Clinical Research Center, Toulouse, Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Alessandra BURA-RIVIERE, Pr, Principal investigator, University Hospital of Toulouse, Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211028
- Sponsor's protocol ID
- 0405402
- Acronym
- ACELLDREAM
- Status last verified
- May 2017
- First submitted
- 31 Mar 2010
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Planat-Benard V, Silvestre JS, Cousin B, Andre M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Penicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. doi: 10.1161/01.CIR.0000114522.38265.61. Epub 2004 Jan 20.
PubMed 14734516
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Autologous Adipose Derived Stroma/Stem Cells to Treat Critical Leg Ischemia.
- ClinicalTrials.gov ID
- NCT01211028
- Acronym / sponsor ID
- ACELLDREAM / 0405402
- Keywords
- Critical leg ischemia, Adipose derived Stroma/Stem Cells, Autologous, Angiogenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- French Blood Establishment, Clinical Research Center, Toulouse, Centre National de la Recherche Scientifique, France
- Study start
- Jan 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Sep 2010 (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 main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with expanded adipose derived stroma/stem cells sue, administered intramuscularly in patients with critical leg ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous ASCs | Other | Biological: Expanded autologous ASCsExpanded autologous ASCs (Adipose Stroma/Stem Cells) Intramuscular dose of 100 million expanded cells. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe peripheral vascular disease not amenable to bypass or angioplasty
- Age >40 years old
- Normal renal function (creatinine < 1.6)
- Non pregnant female
- Lifespan > 6 months
Key exclusion criteria (11 listed)
- Age <40 years old
- Refusal to give informed consent and/orCognitively disabled
- Congestive heart failure or stroke in the last 3 months
- History of cancer or myeloproliferative disorders
- Proliferative 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 |
|---|---|---|
| Expanded autologous ASCsAlso: Expanded autologous Adipose-derived adult Stroma/Stem cellsDrug: Expanded autologous adipose-derived adult stroma/stem cells | Biological | Autologous ASCs |
Primary outcome
Number and Nature of Adverse Events : safety and tolerability
Time frame: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record
To evaluate safety and tolerability related to the intramuscular injection of autologous adipose derived stroma/ stem cells. [ Designated as safety issue: Yes ]
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 11 May 2017.
- Background: PubMed 14734516Planat-Benard V, Silvestre JS, Cousin B, Andre M, Nibbelink M, Tamarat R, Clergue M, Manneville C, Saillan-Barreau C, Duriez M, Tedgui A, Levy B, Penicaud L, Casteilla L. Plasticity of human adipose lineage cells toward endothelial cells: physiological and therapeutic perspectives. Circulation. 2004 Feb 10;109(5):656-63. doi: 10.1161/01.CIR.0000114522.38265.61. Epub 2004 Jan 20.
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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.
Alessandra BURA-RIVIERE, Pr principal investigator
University Hospital of Toulouse, Rangueil
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 Expanded autologous ASCs in people with Peripheral Vascular Diseases and Cardiovascular Diseases, run by University Hospital, Toulouse 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 5 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 11 May 2017. 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 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?
Number and Nature of Adverse Events : safety and tolerability (time frame: 15 days, 1, 2, 3, 4,5, 6 months for adverse events record). 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 NCT01211028, 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 11 May 2017.