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

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ClinicalTrials.gov Identifier: NCT02993809
Recruitment Status : Not yet recruiting
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
South China Research Center for Stem Cell and Regenerative Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Leg Ulcer Diabetic Foot Gangrene Peripheral Vascular Disease Ischemia Biological: BM-ECs and PRPE Biological: BM-ECs Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2018
Estimated Primary Completion Date : December 2019

Arm Intervention/treatment
Experimental: BM-ECs and PRPE
Multipoint of intramuscular injections into ischemic limbs.Injections composed of bone marrow derived endothelial cells (BM-ECs) and platelet-rich plasma extract (PRPE).
Biological: BM-ECs and PRPE
Active Comparator: BM-ECs
Intramuscular injection of bone marrow derived endothelial cells only.
Biological: BM-ECs



Primary Outcome Measures :
  1. Survival without major amputation [ Time Frame: 6 months after implantation ]

Secondary Outcome Measures :
  1. Perfusion rate in treated tissue by measure of ankle-brachial index (ABI) [ Time Frame: Within 6 months after implantation ]
  2. Perfusion rate in treated tissue by transcutaneous PO2 (TcPO2) [ Time Frame: Within 6 months after implantation ]
  3. Perfusion rate in treated tissue by digital subtraction angiography (DSA) [ Time Frame: Within 6 months after implantation ]
  4. wound size [ Time Frame: Within 6 months after implantation ]
  5. wound stage [ Time Frame: Within 6 months after implantation ]
  6. Pain intensity [ Time Frame: Within 6 months after implantation ]
    Pain intensity using Visual Analogue Scale

  7. Thermography [ Time Frame: Within 6 months after implantation ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993809


Contacts
Contact: Xuetao Pei, M.D., Ph.D 8610-68164807 AMMS0906@163.com
Contact: Fang Fang, Ph.D 8620-89199011 fangfang@scrm.org.cn

Sponsors and Collaborators
South China Research Center for Stem Cell and Regenerative Medicine

Responsible Party: South China Research Center for Stem Cell and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT02993809     History of Changes
Other Study ID Numbers: BMEC-PRPE
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Ischemia
Diabetic Foot
Vascular Diseases
Leg Ulcer
Peripheral Vascular Diseases
Peripheral Arterial Disease
Gangrene
Pathologic Processes
Diabetic Angiopathies
Cardiovascular Diseases
Foot Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Necrosis