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

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

Sponsors

Lead Sponsor: Xuanwu Hospital, Beijing

Collaborator: Thermogenesis Corp.
Hebei Medical University

Source Xuanwu Hospital, Beijing
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.

Overall Status Unknown status
Start Date 2011-10-01
Completion Date 2013-04-01
Primary Completion Date 2012-04-01
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Cell treatment-related adverse event 2-wk after bone marrow transplantation
Secondary Outcome
Measure Time Frame
ulcer size Post bone marrow transplantation: 1, 3, 6, 12 months
rest pain score. Post bone marrow transplantation: 1,3, 6, 12 months
cold sensation score Post bone marrow transplantation:,1,3, 6, 12 months
claudication distance (m) Post bone marrow transplantation:1, 3, 6, 12 months
Resting ABI Post bone marrow transplantation: 1,3, 6, 12 months
Resting TcPO2 (mmHg) Post bone marrow transplantation:1, 3, 6, 12 months
Collateral vessel score Post bone marrow transplantation: 1,3, 6, 12 months
Amputation rate Post bone marrow transplantation:1, 3, 6, 12 months
Skin microcirculation measurement 1,3,6,12 months post transplantation
Resting TBI Post bone marrow transplantation: 1,3, 6, 12 months
Enrollment 50
Condition
Intervention

Intervention Type: Device

Intervention Name: ResQ processed bone marrow sample

Description: Autologous bone marrow is processed with ResQ at point of care, prior to the transplantation

Arm Group Label: ResQ process group

Intervention Type: Device

Intervention Name: Ficoll conventional cell processing method

Description: Comparison of different cell processing methods

Arm Group Label: Ficoll-based conventional method

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

Minimum Age:

20 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yong-Quan Gu, Dr. Principal Investigator Xuanwu Hospital, Beijing
Overall Contact

Last Name: Yongquan Gu, MD

Phone: 13910002909

Email: [email protected]

Location
Facility: Contact: Investigator: Xuan Wu Hospital Yongquan Gu, MD 13910002909 [email protected] Yongquan Gu, MD Principal Investigator
Location Countries

China

Verification Date

2011-10-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Xuanwu Hospital, Beijing

Investigator Full Name: Yong-Quan Gu

Investigator Title: Director of Vascular Surgery Department, Principal Investigator, Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: ResQ process group

Type: Experimental

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.

Label: Ficoll-based conventional method

Type: Active Comparator

Description: A conventional method based on Ficoll cell separation is used to process bone marrow.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News