Autologous Transplantation of BM-ECs With Platelet-Rich Plasma Extract for the Treatment of Critical Limb Ischemia

Diabetic Foot Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02993809
• Other study ID #: BMEC-PRPE
• Status: Not yet recruiting
• Phase: Phase 1
• First received: November 23, 2016
• Last updated: December 13, 2016
• Start date: March 2018

Study information

• Verified date: September 2016
• Source: South China Research Center for Stem Cell and Regenerative Medicine
• Contact: Xuetao Pei, M.D., Ph.D
• Phone: 8610-68164807
• Email: AMMS0906[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The intent of this clinical study is to evaluate the safety of the injection composed of autologous bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE) for the treatment of critical limb ischemia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Limb ischemia patients(e.g. arteriosclerosis obliterans,diabetic critical limb ischemia, thromboangitis obliterans)

1. 18 Years to 80 Years (Adult, Senior);

2. Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;

3. Patient meets at least one of the following diagnostic criteria for the index limb:

1. ABI<0.7mmHg

2. TcpO2 <40 mm Hg

3. Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization;

4. Have no improvement after conservative treatment and are not suitable for surgical bypass surgery because no outflow tract of diseased vessel can be found by imaging;

5. Despite having good outflow artery, but the elderly and frail patients can also not tolerate revascularization or interventional surgery;

6. Unlikelihood of major amputation of the leg during the next 12 months;

7. Expected life span more than 2 years.

Exclusion Criteria:

1. Pregnant or lactating;

2. Diabetics with poorly controlled blood glucose levels (defined as HbA1c>7% and/or proliferative retinopathy);

3. Patients with decompensated cardiac, renal or liver disease;

4. Patients with confirmed malignant tumor;

5. Subjects are with serious heart, liver, kidney and lung failure or under poor general condition that are inability to undergo bone marrow harvesting and transplantation;

6. Known or suspected disease of the immune system or osteomyelitis;

7. Inability to sign informed consent form and to comply with the schedule of the study;

8. There has reason to suspect that the patient is forced to join the study;

9. Any other condition, in the opinion of the investigator, would render the patient unsuitable for the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Gangrene
• Ischemia
• Leg Ulcer
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Biological:
• BM-ECs and PRPE

• BM-ECs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
South China Research Center for Stem Cell and Regenerative Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without major amputation		6 months after implantation	Yes
Secondary	Perfusion rate in treated tissue by measure of ankle-brachial index (ABI)		Within 6 months after implantation	No
Secondary	Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2)		Within 6 months after implantation	No
Secondary	Perfusion rate in treated tissue by digital subtraction angiography (DSA)		Within 6 months after implantation	No
Secondary	wound size		Within 6 months after implantation	No
Secondary	wound stage		Within 6 months after implantation	No
Secondary	Pain intensity	Pain intensity using Visual Analogue Scale	Within 6 months after implantation	No
Secondary	Thermography		Within 6 months after implantation	No