Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia

NCT01937416 | Unknown Phase 1 DMC

• 1 other identifier: 12276102D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and efficacy of autologous bone marrow mononuclear cells transplantation in diabetic patients with lower limb ischemia.

Conditions

Diabetes; Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Cell transplantation related side effect

  Temperature,pulse,respiration,blood pressure,routine analysis of blood and urine, liver function,renal function,function of coagulation, ECG,cell transplantation related death and cell transplantation related unexpected amputation

  2 week after cell transplantation

Secondary Outcomes (7)

• ulcer size

  Post cell transplantation: 1, 3, 6 months

• rest pain score

  Post cell transplantation: 1,3, 6 months

• cold sensation score

  Post cell transplantation: 1,3, 6 months

• Resting ABI

  Post cell transplantation: 1,3, 6 months

• Resting TcPO2 (mmHg)

  Post cell transplantation:1, 3, 6 months

Study Arms (1)

autologous bone marrow mononuclear cells

EXPERIMENTAL

Bone marrow come from the patients himself/herself. With a conventional method and reagent,Ficoll, mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation.

Biological: autologous bone marrow mononuclear cells

Interventions

autologous bone marrow mononuclear cells BIOLOGICAL

Bone marrow was taken from patient oneself and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection.

autologous bone marrow mononuclear cells

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fontaine's stage 2-4 or resting ABI \<0.7
• age between 20 and 80 years old
• sign informed consent, voluntary subjects
• diagnosis of diabetic lower limb ischemia

You may not qualify if:

• poorly controlled diabetes (HBA1c\> 7.0%) and proliferative retinopathy (III-IV stage)
• malignancy history in the past five years or serum level of tumor markers elevated more than doubled
• severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate bone marrow mononuclear cells transplantation
• serious infections (such as cellulitis, osteomyelitis, etc.)
• pregnant female, or reproductive age female who wants to give birth throughout the course of the study
• life expectancy less than half a year

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Baoyong Yan, Doctor

  The First Hospital of Hebei Medical University

  STUDY CHAIR

• Huimin Zhou, doctor

  The First Hospital of Hebei Medical University

  STUDY DIRECTOR

• Xu Han, master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Quanhai Li, doctor

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 9, 2013
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

CN (1)