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Critical Limb IschemiaPhase 1/2NCT01446055

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

A Phase 1/2 study testing ResQ processed bone marrow sample and Ficoll conventional cell processing method in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
ResQ processed bone marrow sample and Ficoll conventional cell processing method
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
Oct 2011to Apr 2013
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • fontaine's stage 2-4 or resting ABI <0.7
  • age between 20 and 80 years old
  • sign informed consent, voluntary subjects
  • diagnosis of lower extremity arterial occlusive disease, or diabetic lower limb ischemia, or Buerger's disease

Who cannot join

  • poorly controlled diabetes (HBA1c> 7.0%) and proliferative retinopathy (III-IV stage)
  • malignancy history in the past five years or serum level of tumor markers elevated more than doubled
  • severe heart, liver, kidney, respiratory failure or poor general condition can not tolerate BM-MNC transplantation
  • serious infections (such as cellulitis, osteomyelitis, etc.)or gangrene that a major amputation cannot be avoided
  • aortic or iliac or common femoral artery occlusion
  • pregnant female, or reproductive age female who wants to give birth throughout the course of the study
  • life expectancy less than a year

Trial locations and contacts

1 site in 1 country.

Yongquan Gu, MD contact

13910002909

gu-yq@263.net

China1 site

  • Xuan Wu Hospital

    Beijing, Beijing Municipality

    Yongquan Gu, MD, 13910002909, gu-yq@263.net

    Yongquan Gu, MD

Other trials in China

About this study

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

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.

Read the 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.

Being tested
ResQ processed bone marrow sample, Ficoll conventional cell processing method
Keywords
Peripheral arterial disease, Buerger's disease, atherosclerotic arterial occlusion, bone marrow mononuclear cell, chronic limb ischemia
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Thromboangiitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResQ processed bone marrow sampleDevice

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

  • Ficoll conventional cell processing methodDevice

    Comparison of different cell processing methods

Study groups in NCT01446055
Study groupRoleWhat they receive
ResQ process groupExperimentalAutologous BM-MNC is enriched with ResQ process(an automatic cell separator). Then the cell product is transplanted into the ischemia limbs of a patient.
Receives: Device: ResQ processed bone marrow sample
Ficoll-based conventional methodActive comparatorA conventional method based on Ficoll cell separation is used to process bone marrow.
Receives: Device: Ficoll conventional cell processing method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cell treatment-related adverse event

    1. Temperature,Pulse,Respiration,Blood Pressure
    2. Routine analysis of blood and urine,
    3. Liver function(ALT：alanine aminotransferase,AST：aspartate transferase), Renal function(Blood urea nitrogen,Creatinine;) Function of coagulation(APTT,PT,Fib,TT）
    4. ECG（Electrocardiography）
    5. local inflammatory response
    6. Cell-treatment related death
    7. Cell-treatment related unexpected amputation.

    Measured: 2-wk after bone marrow transplantation

Secondary outcomes (10)

  1. ulcer size

    Measuring ulcer area (cm2) and depth (mm)of limb :

    For each ulcer , photographically record the area and depth with a ruler in order to calculate the ulcer area in square millimeters.

    Measured: Post bone marrow transplantation: 1, 3, 6, 12 months

  2. rest pain score.

    Scoring the rest pain based on the degree of pain as following five scales):

    0 level-0 point: no pain;

    1. level-1 point: occasional pain which can be recalled;
    2. level-2 points: the pain often but can be tolerated, without or with a little analgesics;
    3. level-3 points: often with need of general analgesics;
    4. level -4 points: affect sleeping due to the pain, general pain medication being difficult to alleviate.

    Before transplantation: points; after transplantation: points.

    Measured: Post bone marrow transplantation: 1，3, 6, 12 months

  3. cold sensation score

    based on a sense of cold as following five scales: 0 level-0 point: no cold sensation;

    1. level-1 point, or : Accasionally cold feeling;
    2. level-2 points: Often with cold feeling;
    3. level-3 points: significantly cold feeling. and can be significantly improved when using a local insulation.
    4. level-4 points: significantly cold feeling，and can not be significantly improved when using a local insulation.

    Measured: Post bone marrow transplantation:,1，3, 6, 12 months

  4. claudication distance (m)

    Measurement of claudication distance (m)： For patients with intermittent claudication, treadmill exercise test (no tilt, speed 3km/hr) is employed to measure claudication distance.

    Measured: Post bone marrow transplantation:1, 3, 6, 12 months

  5. Resting ABI

    Measurement of ABI(ankle brachial index, ABI):

    Measure arterial pressure with a laser Doppler, and then calculate the ankle-brachial index, that is a ratio of ankle arterial blood pressure to brachial arterial blood pressure at rest.

    Measured: Post bone marrow transplantation: 1,3, 6, 12 months

  6. Resting TcPO2 (mmHg)

    Transcutaneous oxygen pressure(TcPO2) should be measured at the same site in the ischemic limb at rest.

    Measured: Post bone marrow transplantation:1, 3, 6, 12 months

  7. Collateral vessel score

    Collateral vessel score:

    Using DSA(Digital subtraction angiography)or CTA(computed tomographic angiography) to score the collateral vessel formation.

    A mean score is obtained for each ischemic limb by 3 independent interventionists based on the following 4 level score:

    0 (no new collateral vessels)

    • 1 (A little new collateral vessels)
    • 2 (moderate new collateral blood vessels)
    • 3 (Rich new collateral vessels)

    Measured: Post bone marrow transplantation: 1,3, 6, 12 months

  8. Amputation rate

    Amputation rate and level is recorded.

    Measured: Post bone marrow transplantation:1, 3, 6, 12 months

  9. Skin microcirculation measurement

    using PeriMed "laser-Doppler flowmetry" measure the skin microcirculation on the same site in the ischemic limb at rest.

    Measured: 1,3,6,12 months post transplantation

  10. Resting TBI

    Measurement of TBI（Toe Brachial Index):

    Measure arterial pressure with a laser Doppler, and then calculate Toe Brachial Index, that is a ratio of toe arterial blood pressure to brachial arterial blood pressure.

    Measured: Post bone marrow transplantation: 1,3, 6, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionApr 2012 (estimated)
  4. Study completionApr 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01446055
Sponsor's protocol ID
TGResQ082011
Status last verified
Oct 2011
First submitted
23 Sep 2011
Last updated
12 Oct 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ResQ processed bone marrow sample and Ficoll conventional cell processing method in people with Critical Limb Ischemia and Peripheral Arterial Disease, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongquan Gu, MD (13910002909, gu-yq@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell treatment-related adverse event (time frame: 2-wk after bone marrow transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01446055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.

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