Clinical trial NCT01937416: Autologous Bone Marrow Mononuclear Cells Therapy in Diabetic Lower Limb Ischemia
Official title: Safety and Efficacy Investigation of Patients With Diabetic Lower Limb Ischemia by Transplantation of Autologous Bone Marrow Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes
Lower Limb Ischemia
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Diabetic lower limb ischemia as severe complication of diabetes influences the life quality of patients and currently the effective treatment for the disease is lacking. Bone marrow mononuclear cells have been proved to have multiple functions including the differentiation and proliferation. In animal model, bone marrow mononuclear cells could induce angiogenesis and may have therapeutic usage for ischemia disease. The investigators thereby design the study to investigate the possible therapy of diabetic lower limb ischemia with autologous bone marrow mononuclear cells. Patient with diabetic lower limb ischemia was treated with colony stimulating factor for improvement of bone marrow hematopoiesis. Then bone marrow was taken 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. The investigators investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, routine analysis of blood and urine etc. post the transplantation. And the efficacy was evaluated with the measurement of ulcer size, rest pain score, cold sensation score, resting ABI, resting TcPO2, collateral vessel score and skin microcirculation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Cell transplantation related side effect
timeFrame: 2 week after cell transplantation
Secondary outcomes:
measure: ulcer size
timeFrame: Post cell transplantation: 1, 3, 6 months
measure: rest pain score
timeFrame: Post cell transplantation: 1,3, 6 months
measure: cold sensation score
timeFrame: Post cell transplantation: 1,3, 6 months
measure: Resting ABI
timeFrame: Post cell transplantation: 1,3, 6 months
measure: Resting TcPO2 (mmHg)
timeFrame: Post cell transplantation:1, 3, 6 months
measure: Collateral vessel score
timeFrame: Post cell transplantation: 1,3, 6 months
measure: Skin microcirculation measurement
timeFrame: 1,3,6 months post cell transplantation
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Baoyong Yan, Doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Huimin Zhou, doctor
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Xu Han, master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Quanhai Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: