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Infarction, Middle Cerebral ArteryPhase 1NCT00473057

Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke

A Phase 1 study testing Autologous cell transplantation in people with Infarction, Middle Cerebral Artery, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Infarction, Middle Cerebral Artery
What is being tested?
Autologous cell transplantation
Type of treatment
Injection or infusion
How many people
12 participants
Where
1 siteBrazil
Study dates
Dec 2005to May 2011
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset
  • neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory
  • age between 18 and 75 years old
  • NIHSS between 4 and 20
  • spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI
  • signed informed consent

Who cannot join

  • difficult in obtaining vascular access for percutaneous procedures
  • vascular impossibility to reach the middle cerebral artery through percutaneous approach
  • severe carotid stenosis( >70%, by Doppler) related to the severe stroke
  • neurological worsening (>4 points in the NIHSS ) due to edema or intracerebral hemorrhage
  • primary hematological disease
  • neurodegenerative disorder
Show all 18Show fewer
  • previous stroke with mRS > 2
  • intracardiac thrombosis
  • auto-imune disorders
  • osteopathies that could increase the risk of bone marrow harvesting procedure
  • thrombophilias
  • liver failure
  • chronic renal failure (creatinine > 2mg/ml)
  • life support dependence
  • lacunar stroke
  • pregnancy
  • history of neoplasia or other comorbidity that could impact patient's short-term survival
  • any condition that in the judgment of the investigator would place the patient under undue risk

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Universitário Clementino Fraga Filho/UFRJ

    Rio de Janeiro, Rio de Janeiro, 21.941-590

Other trials in Brazil

About this study

Official title: Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke

This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.

Read the detailed description

Objective: The purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-acute phase (> 3 and < 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory.

Methods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. The procedure is monitored by Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.

Being tested
Autologous cell transplantation
Keywords
acute stroke, middle cerebral artery, autologous transplantation, bone marrow cells, stem cells, cell therapy
Medical subject headings
Infarction, Middle Cerebral Artery, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous cell transplantationOther

    Intra-arterial or intravenous delivery of autologous bone marrow cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.

    Measured: 4 months

Secondary outcomes (2)

  1. Improvement of neurological deficits

    Measured: 4 months

  2. Improvement in the neuroimaging exams

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2007 (estimated)
  2. Study startDec 2005
  3. Primary completionMay 2011
  4. Study completionMay 2011

Resources

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00473057
Sponsor's protocol ID
CONEP-10385
Other IDs
CEP-HUCFF/UFRJ-169/03, Proc.-CNPq-55.2201/2005-7
Status last verified
May 2011
First submitted
10 May 2007
Last updated
19 May 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous cell transplantation in people with Infarction, Middle Cerebral Artery, run by Universidade Federal do Rio de Janeiro 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 6 inclusion and 18 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 19 May 2011. 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?

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?

Absence of new neurological deficits during the procedure and/or in the 4 months follow-up. (time frame: 4 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 NCT00473057.

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 19 May 2011.

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