Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia

Brief Title

Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia

Official Title

Transplantation of Autologous BM-MNC Processed by ResQ Separator and Conventional Manual Method for Patients With Chronic Limb Ischemia: a Multi-center Randomized Controlled Trial

Brief Summary

      Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb
      ischemia has been proved safe and effective. However, processing bone marrow by Ficoll
      density gradient centrifugation is not only time consuming but also expensive. Manually
      processing of bone marrow also results in large variation in therapeutic cell quantity and
      quality which directly leads deviation of safety and efficacy of the cell therapy. This study
      is aiming to compare an automated bone marrow processing system with a conventional manual
      method in term of safety and efficacy.
    

Detailed Description

      Using autologous bone marrow mononuclear cells (BM-MNC) to treat patients with chronic limb
      ischemia has been proved safe and effective. However, processing bone marrow by Ficoll
      density gradient centrifugation is not only time consuming but also expensive. Manually
      processing of bone marrow also results in large variation in therapeutic cell quantity and
      quality which directly lead deviation of safety and efficacy of the cell therapy. This study
      is aiming to compare an automated bone marrow processing system with a conventional manual
      method in term of safety and efficacy.

      ResQ system developed by Thermogenesis in USA provides an automatic cell processing system
      for bone marrow. The system takes less than 30 minutes to concentrate the therapeutic
      mononuclear cells including stem cells in a closed system without adding any additive such as
      separation reagent (Ficoll). The system also be able to be operated at point of care.

      The study is designed to prove no inferior of safety and efficacy of bone marrow cells
      processed by ResQ to those of cells using conventional manual method. The conventional manual
      method is involved Ficoll density gradient centrifugation and cell washing stems in an open
      system. Each of test arms (ResQ vs manual method) consists of 25 patients. The primary
      outcome is safety which is measured by cell treatment-related adverse events. The secondary
      endpoints include resting ankle-brachial pressure index (ABI)and toe brachial pressure index
      (TBI) , transcutaneous oxygen pressure (TcPO2), claudication distance, rest pain scale
      evaluation, collateral vessel scale, etc.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Cell treatment-related adverse event

Secondary Outcome

 ulcer size

Condition

Critical Limb Ischemia

Intervention

ResQ processed bone marrow sample

Study Arms / Comparison Groups

 ResQ process group
Description:  Autologous BM-MNC is enriched with ResQ process(an automatic cell separator). Then the cell product is transplanted into the ischemia limbs of a patient.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

50

Start Date

October 2011

Completion Date

April 2013

Primary Completion Date

April 2012

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 lower extremity arterial occlusive disease, or diabetic lower limb
             ischemia, or Buerger's disease

        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 BM-MNC transplantation

          4. serious infections (such as cellulitis, osteomyelitis, etc.)or gangrene that a major
             amputation cannot be avoided

          5. aortic or iliac or common femoral artery occlusion

          6. pregnant female, or reproductive age female who wants to give birth throughout the
             course of the study

          7. life expectancy less than a year
      

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Yong-Quan Gu, Dr., 13910002909, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT01446055

Organization ID

TGResQ082011


Responsible Party

Principal Investigator

Study Sponsor

Xuanwu Hospital, Beijing

Collaborators

 Thermogenesis Corp.

Study Sponsor

Yong-Quan Gu, Dr., Principal Investigator, Xuanwu Hospital, Beijing


Verification Date

October 2011