Critical Limb IschemiaPhase 1NCT00488020
Stem Cells for Treating Critical Ischemia
A Phase 1 study testing stem cells transplant in people with Critical Limb Ischemia and Ischemic Ulcers, run by Instituto de Molestias Cardiovasculares at 1 site in Brazil.
Trial summary
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Critical Limb Ischemia, Ischemic Ulcers
- What is being tested?
- stem cells transplant
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2006to Jun 2007
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fontaine's classification grade 3 and 4 patients
Who cannot join
- Record of cancer in the last 5 years
- Over 80 years
- Diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Molestias Cardiovasculares
São José do Rio Preto, São Paulo, 15015-210
Jose D Araujo, MD, 551732034000 ext. 112, imc.terapia.celular@terra.com br
About this study
Official title: the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
Read the detailed description
About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed
- Conditions
- Critical Limb Ischemia, Ischemic Ulcers
- Being tested
- stem cells transplant
- Keywords
- rest pain, ischemic ulcers
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cells transplantProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppress pain and heal ischemic ulcers
Measured: 6 months
Secondary outcomes (1)
improve quality of life
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 Jun 2007 (estimated)
- Study startApr 2006
- Study completionJun 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Molestias Cardiovasculares
- Sponsor type
- University, hospital or other
- Investigators
- Jose D Araújo, MD, Principal investigator, Instituto de Molestias Cardiovasculares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488020
- Sponsor's protocol ID
- imc1
- Status last verified
- Jun 2007
- First submitted
- 15 Jun 2007
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Use of Autogenous Adult Stem Cells in the Treatment of Critical Ischemia
- ClinicalTrials.gov ID
- NCT00488020
- Acronym / sponsor ID
- imc1
- Conditions
- Critical Limb Ischemia, Ischemic Ulcers
- Keywords
- rest pain, ischemic ulcers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Instituto de Molestias CardiovascularesUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Jun 2007 (estimated)
- First posted
- 19 Jun 2007 (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.
Collection of bone marrow blood Selection of mononuclear cells dilution with albumin injection into the calf muscles through 40 shots
Detailed description
About 500cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution in albumin (40cc)the mononuclear cells are injected into the calf muscles through 40 shots.This procedure is indicated for patients with lower limb ischemia on whom all the others known therapies have failed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fontaine's classification grade 3 and 4 patients
Key exclusion criteria (3 listed)
- Record of cancer in the last 5 years
- Over 80 years
- Diabetic 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 |
|---|---|---|
| stem cells transplant | Procedure or surgery | – |
Primary outcome
Suppress pain and heal ischemic ulcers
Time frame: 6 months
1 secondary outcome
improve quality of life
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 13 Jun 2008.
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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.
Jose D Araújo, MD principal investigator
Instituto de Molestias Cardiovasculares
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 stem cells transplant in people with Critical Limb Ischemia and Ischemic Ulcers, run by Instituto de Molestias Cardiovasculares at 1 site in Brazil.
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 1 inclusion and 3 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 13 Jun 2008. 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 Brazil. 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 Jose D Araújo, MD (551732034000, imc.terapia.celular@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suppress pain and heal ischemic ulcers (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 13 Jun 2008; AzTrials last refreshed its copy on 28 Oct 2026.