Safety and Feasibility Study of Autologous Progenitor Cell Transplantation in Diabetic Neuropathy

(Restoration of Nerve Functions by Intra-arterial Transplantation of Bone Marrow Progenitor Cells in Patients With Diabetic Poly Neuropathy (PNP)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00282685

Enrollment

Registered

2006-01-27

Start date

2005-10-31

Completion date

2009-10-31

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

Patients with symmetric peripheral diabetic neuropathy

Brief summary

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

Interventions

PROCEDUREIntraarterial bone marrow progenitor cell transplantation

catheter delivery of stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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) * 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

Design outcomes

Primary

Measure	Time frame
Improvement of neurological score: modified NIS(LL)+7	1 year

Secondary

Measure	Time frame
Modified Toronto Clinical Scoring System	1 year
Heart rate variability	1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026