Diabetic NeuropathiesPhase 1NCT00282685
Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy
A Phase 1 study testing Intraarterial bone marrow progenitor cell transplantation in people with Diabetic Neuropathies, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Intraarterial bone marrow progenitor cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2005to Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with distal symmetrical diabetic neuropathy of the legs
- Type 1 or Type 2 Diabetes
- Stable Glucose control over last 3 months (Hba1c <7.5)
- Written informed consent
Who cannot join
- Patients with peripheral arterial disease (ABI <0.9)
- Neuropathy of other origin
- Myopathy
- Asymmetrical neuropathy
- Active infection oder fever
- Chronic inflammatory disease (z.B M. Crohn, Rheumatoid Arthritis)
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- HIV or hepatitis
- Neoplastic disease without complete remission within last 5 y
- Stroke or myocardial infarction within last 3 months
- Renal failure (creatinine > 2 mg/dl)
- Liver disease (GOT > 2 upper limit or spontaneous INR > 1,5).
- Anemia (hemoglobine < 8.5 mg/dl)
- Platelets <100.000/µl
- HbA1c >7,5 %
- Allergies to Aspirin, Clopidogrel, Heparin
- Bleeding disorder
- Surgery or trauma within the last 2 months
- Pregnancy
- Mental retardation
- Participation in another study within 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.
Read the detailed description
Goal is:
Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function
- Conditions
- Diabetic Neuropathies
- Being tested
- Intraarterial bone marrow progenitor cell transplantation
- Keywords
- Patients with symmetric peripheral diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraarterial bone marrow progenitor cell transplantationProcedure or surgery
catheter delivery of stem cells
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial stemcell therapy | Experimental | Patients were treated with intra-arterial stemcells delivered via catheter examination Receives: Procedure: Intraarterial bone marrow progenitor cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of neurological score: modified NIS(LL)+7
Measured: 1 year
Secondary outcomes (2)
Modified Toronto Clinical Scoring System
Measured: 1 year
Heart rate variability
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. M. Zeiher, Johann Wolfgang Goethe University Hospital
- Investigators
- Andreas M Zeiher, MD, Principal investigator, Div. of Cardiology, University of Frankfurt, GermanyDirk H Walter, MD, Study director, Div. of Cardiology, University of Frankfurt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282685
- Sponsor's protocol ID
- 2005-000969-19
- Other IDs
- RENERVATE, 2005
- Status last verified
- Oct 2021
- First submitted
- 25 Jan 2006
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)
- ClinicalTrials.gov ID
- NCT00282685
- Acronym / sponsor ID
- 2005-000969-19
- Conditions
- Diabetic Neuropathies
- Keywords
- Patients with symmetric peripheral diabetic neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Jan 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.
Treatment of patients with diabetic neuropathy by intraarterial progenitor cell transplantation.
Detailed description
Goal is:
Stimulation of angiogenesis and induction of vasa nervorum in order to improve nerve function
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial stemcell therapy | Experimental | Procedure: Intraarterial bone marrow progenitor cell transplantationPatients were treated with intra-arterial stemcells delivered via catheter examination |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with distal symmetrical diabetic neuropathy of the legs
- Type 1 or Type 2 Diabetes
- Stable Glucose control over last 3 months (Hba1c <7.5)
- Written informed consent
Key exclusion criteria (20 listed)
- Patients with peripheral arterial disease (ABI <0.9)
- Neuropathy of other origin
- Myopathy
- Asymmetrical neuropathy
- Active infection oder fever
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 |
|---|---|---|
| Intraarterial bone marrow progenitor cell transplantationcatheter delivery of stem cells | Procedure or surgery | Intra-arterial stemcell therapy |
Primary outcome
Improvement of neurological score: modified NIS(LL)+7
Time frame: 1 year
2 secondary outcomes
Modified Toronto Clinical Scoring System
Time frame: 1 year
Heart rate variability
Time frame: 1 year
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 26 Oct 2021.
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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.
Andreas M Zeiher, MD principal investigator
Div. of Cardiology, University of Frankfurt, Germany
Dirk H Walter, MD study director
Div. of Cardiology, University of Frankfurt, Germany
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 Intraarterial bone marrow progenitor cell transplantation in people with Diabetic Neuropathies, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 4 inclusion and 20 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 26 Oct 2021. 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 Germany. 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?
Improvement of neurological score: modified NIS(LL)+7 (time frame: 1 year). 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 26 Oct 2021.