A Clinical Study Using Autologous Bone Marrow Stem Cell for Diabetes Related Vascular Complications

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot.This study intends to establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

Study Overview

• Status: Unknown
• Conditions: Ischemia; Diabetic Foot; Peripheral Vascular Disease
• Intervention / Treatment: Biological: mesenchymal stem cells; Biological: saline

Detailed Description

Diabetic foot is one of the most serious chronic complications of diabetic patients, and still lacking effective treatments.

Stem cell therapy has been a new and effective therapy in recent years for diabetic foot. Combined with the previous studies of our research group, this study intends to transform part of the results of this research, establish an optimal clinical research program, and attempts to break the technical bottleneck in the stem cell therapy for treating diabetes related vascular complications.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes mellitus Type 2 or Type 1
• Age between 18-80 years
• Chronic foot ulcer more than 6 weeks
• No sufficient response to best standard care delivered for six weeks.
• PAD up to Fontaine stage III or IV period
• CLI with the ankle brachial index (index ankle-brachial, ABI) <0.7 and (or) the percutaneous oxygen partial pressure (oxygen tension transcutaneous, TcPO2) <30mmHg

Exclusion Criteria:

• HbA1c >12%
• Hemoglobin <10 mg/dl
• Creatinine clearance rate <30ml/min
• Systemic bacterial, viral infections (Mei Du, hepatitis, cytomegalovirus infection, HIV, B19 infection, herpes virus infection) and sepsis
• Have accepted the treatment of stem cells or growth factors
• Have a history of malignant disease
• Pregnancy
• Mental illness history
• Abnormal coagulation function
• Allergic reaction
• Severe cardiac insufficiency (III-IV NYHA)
• Using vasoactive substances

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous Bone Marrow Stem Cell; Mesenchymal stem cells derived from bone marrow infusion	Biological: mesenchymal stem cells; stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
Placebo Comparator: saline; saline injections	Biological: saline; saline injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area of diabetic foot ulcers	To determine the ability of MSC to facilitate and accelerate diabetic foot ulcers healing.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of transcutaneous oxygen partial pressure (TcPO2)	Improvement of local perfusion.	3 months
Improvement of microvascular cutaneous reactivity by laser Doppler perfusion monitoring (LDPM)		3 months
Pain (Visual-Analog Scale)	Measure of the subjective symptom of pain.	3 months
Walking distance (treadmill) if possible		3 months

Collaborators and Investigators

• Sponsor: Jie Shen
• Collaborators: Nanfang Hospital of Southern Medical University; Southern Medical University, China; Academy Military Medical Science, China; The Fifth Affiliated Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 10, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Skin Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Atherosclerosis; Foot Ulcer; Diabetic Foot; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: ThirdSouthernMedical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No