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Autologous Bone Marrow Mononuclear Cells Transplantation in Treating Diabetes Patients

Autologous Bone Marrow Mononuclear Cell Transplantation in Treating Patients With Type 1 or 2 Diabetes Mellitus-a Phase 1/2 Study

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00465478
Enrollment
200
Registered
2007-04-25
Start date
2006-03-31
Completion date
2014-03-31
Last updated
2007-04-25

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

Conditions

Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Bone Marros Mononuclear Cells, Transplantation

Brief summary

The study evaluates the safety and efficiency of autologous bone marrow mononuclear cell transplantation in treating patients with type 1 or 2 Diabetes Mellitus. We hypothesize that autologous bone marrow stem cell transplantation will promote β-cells regeneration by directly differentiated from the transplanted BMMCs or stimulated local stem cells regeneration and thus decrease or eliminate the need of exogenous insulin and improve β-cells function.

Detailed description

Patients with type 1 or 2 Diabetes mellitus will be recruited according to eligibility criteria. Bone marrow mononuclear cells (BMMCs) will be separated from the bone marrow aspirate of each patient and be directly delivered to pancreas via splenic artery with the distal lumen occlusion through an arterial catheter. All patients will be explained in details about the procedures involved in BMMC transplantation and sign the informed consent for the study; The Ethics Committee of Qilu hospital, ShanDong university approved the treatment protocol. All patients undergo scheduled follow-up evaluations for 5 years after transplantation. Clinical, hematological, metabolical evaluations are performed to analyses the effect of the transplant, Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and will received the regular OHA and/or insulin therapy .They are followed in parallel with transplanted patients and will be subjected to the same follow-up management including extensive endocrinological monitoring, diet and exercise program as transplantation patients during the follow-up.

Interventions

Sponsors

Shandong University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Type 1 or type 2 diabetes * Between 16 to 65 years of age * Requiring daily exogenous insulin injection for the glycaemic control * With poor β-cell function * Body mass index (BMI) \< 28

Exclusion criteria

* Acute or chronic infections * Chronic uncompensated organic insufficiency including heart, liver, renal and lung * Any malignancies, congenital or acquired immunodeficiency * Hematological diseases or coagulopathy * Acute or chronic pancreatitis * History of thoracic or abdominal aorta diseases * Allergy to iodine * Pregnancy

Design outcomes

Primary

MeasureTime frame
Exogenous insulin requirement; Hemoglobin A1C; Glucose and C-peptide level;

Secondary

MeasureTime frame
Safety assessment parameter: amylase, hepatic function,renal function,
lipid profile, autoantibody, Quality of life

Countries

China

Contacts

Primary ContactLi Chen, MD
chenli3@medmail.com.cn0086-531-82169408
Backup ContactXingli Wang, MD PhD
xlwang@bcm.tmc.edu832-355-9939

Outcome results

None listed

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