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Peripheral Arterial DiseasePhase 1NCT00523731

ACPs in Severe PAD/CLI by Direct Intramuscular Injection

A Phase 1 study testing Angiogenic Cell Precursors (ACPs) or Vescell TM in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by TheraVitae Ltd. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI ) Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Angiogenic Cell Precursors (ACPs) or Vescell TM
Type of treatment
Surgery or procedure
How many people
6 participants
Where
1 siteIsrael
Study dates
Jan 2006to Mar 2007
Phase
Phase 1
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene ; or non-healing ischemic ulcers AND
  • Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease:
  • Ankle brachial index < 0.45
  • Toe brachial index < 0.35
  • TcPO2 / TcO2 of < 40 mmHg.
  • The subject is a poor candidate for standard revascularization treatment options for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy
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  • Age 18 to 80 years
  • Male or non-pregnant, non-lactating female
  • Informed consent obtained and consent form signed

Who cannot join

  • Patient having on angiography a meaningful supra popliteal occlusion that may relate to symptoms of CLI.
  • Subjects, who in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation (at or above the ankle) within 4 weeks of start of treatment
  • Patient who received blood transfusions during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
  • Inability to communicate (that may interfere with the clinical evaluation of the patient)
  • Major operation during the preceding 3 months
  • Myocardial infarction or brain infarction or uncontrolled myocardial ischemia or persistent severe heart failure (EF< 25 %) during the preceding 3 months
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  • Significant valvular disease or after valve replacement during the preceding 3 months
  • After heart transplantation
  • Severe cardiomyopathy (EF < 25 %)
  • Renal failure (creatinine > 2 mg/dl )
  • Hepatic failure
  • Anemia (lower than 11mg/dl.hemoglobin for female and lower than 12 mg/dl for male)
  • Abnormal coagulation tests [platelets, PT (INR), PTT]
  • Stroke within the preceding 3 years
  • Malignancy within the preceding 3 years
  • Concurrent chronic or acute infectious disease
  • Severe concurrent medical disease (e.g., septicemia, HIV-1,2/HBV/HCV infections, poorly controlled insulin-dependent diabetes mellitus ; HBA1c >8 % and proliferative retinopathy , systemic lupus erythematosus, multiple sclerosis, amyotrophic lateral sclerosis)
  • Chronic immunomodulating or cytotoxic drugs treatment
  • Patients who have rectal temp. above 38.40C for 2 consecutive days
  • Patient unlikely to be available for follow-up

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Dr. Valentin Fulga

    Tel Viv, P.O.B.4049,Ness Ziona, 74410

Other trials in Israel

About this study

Official title: A Study of Blood-Borne Autologous Angiogenic Cells Precursors Therapy in Patients With Critical Limb Ischemia

Study title: A Study of Blood-Borne Autologous Angiogenic Cell Precursors Therapy in Patients with Critical Limb Ischemia ( ACPs-CLI )

Principle Investigator: Assoc.Prof. Pramook Mutirangura,M.D. Head of Division of Vascular Surgery , Department of Surgery, Faculty of Medicine Siriraj Hospital , Mahidol University, BKK,Thailand

Read more

Study objective : To determine the safety and efficacy of intramuscular injection of blood-borne autologous ACPs in relieving symptoms of critical limb ischemia of patients treated with maximal medical therapy and don't have intravascular or operative revascularization option.

Study Design : A pilot study , a single center, a non-randomized, open-label trial.

Total expected no. of patients : 6 main selection criteria : A. Subjects will have one or more clinical indications diagnostic of CLI such as: distal extremity pain at rest that requires the subject to use analgesics for >2 weeks; or peripheral ischemic ulcer(s); or areas of gangrene ; or non-healing ischemic ulcers AND

  1. Subjects will have one or more of the following hemodynamic indicators of severe peripheral arterial occlusive disease:
  2. Ankle brachial index < 0.45 II. Toe brachial index < 0.35 III. TcPO2 / TcO2 of < 40 mmHg. C. The subject is a poor candidate for standard revascularization treatment for peripheral arterial disease, based on inadequate bypass conduit, or unfavorable anatomy D. Age 18 to 80 years

Investigational Product : At D-8 250 ml of blood drawn from the patients for production of autologous EPCs or ACPs (VescellTM). On D0 ,at least 1.5 million ACPs with viability >75 % suspended in 30 ml sterile cell culture medium will be injected 1.5 cm deep and 1.5 apart by a 23 -gauge needle into the gastrocnemius muscle of the leg chosen (ischemic leg) for treatment. For injection planning a grid of 10X10 cm will be prepared and in each point 1 ml of ACPs suspension will be injected.

The study consists of 4 periods: Screening ( D-14 to-9\& D-8,Treatment(D0),Acute Safety follow-up (D1\&D2),Chronic follow-up (D30 \& D90)period ,total follow-up of each case is 3 months.

Evaluation criteria :

Safety : no.\& duration of adverse event \& serious adverse event Efficacy :Attenuate CLI patients symptoms (Rest pain,Pain-free walking distance,Ulcer size \&Gangrene dimension and intensity)

Read the detailed description

Six patients with Critical Limb Ischemia (CLI) or severe Peripheral Arterial Disease(PAD) will be enrolled, screened, treated with an injection of Blood-Borne Autologous Angiogenic Cell Precursors(ACPs) in to gastrocnemius of the ischemic leg by intramuscular under regional anesthesia. Following injection.

Being tested
Angiogenic Cell Precursors (ACPs) or Vescell TM
Keywords
Stem cells, Rest pain, claudication, chronic ischemic or non-healing ulcers, Angiogenesis, no-option cases
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication

What participants receive

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

  • Angiogenic Cell Precursors (ACPs) or Vescell TMProcedure or surgery

What is being measured

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

  1. Safety

    Measured: 3 months

  2. Evaluate the safety of ACPs intramuscular injection

    Measured: 3 months

  3. Efficacy

    Measured: 3 months

  4. Attenuate CLI patients symptoms as

    Measured: 3 months

  5. Rest pain

    Measured: 3 months

  6. Pain-free walking distance

    Measured: 3 months

  7. Ulcer size

    Measured: 3 months

  8. Gangrene dimension and intensity

    Measured: 3 months

  9. Obtain evidence for improvement of tissue perfusion due to ACPs injection

    Measured: 3 months

Secondary outcomes (2)

  1. Reduction of CLI patients hospitalization time.

    Measured: 3 months

  2. Decrease CLI patient amputation rate.

    Measured: 3 months

Timeline

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

  1. First posted31 Aug 2007 (estimated)
  2. Study startJan 2006
  3. Study completionMar 2007

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00523731
Sponsor's protocol ID
TV-003
Other IDs
ACPs-CLI
Status last verified
Feb 2007
First submitted
30 Aug 2007
Last updated
31 Aug 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Mutirangura P, Ruangsetakit C, Wongwanit C, Chinsakchai K, Porat Y, Belleli A, Czeiger D. Enhancing limb salvage by non-mobilized peripheral blood angiogenic cell precursors therapy in patients with critical limb ischemia. J Med Assoc Thai. 2009 Mar;92(3):320-7.

    PubMed 19301723

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Angiogenic Cell Precursors (ACPs) or Vescell TM in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by TheraVitae Ltd. at 1 site in Israel.

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 9 inclusion and 20 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: finished, as of the sponsor's last update on 31 Aug 2007. 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 Israel. 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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 3 months). The study lists 9 primary outcomes in all. 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 NCT00523731, which also lists 1 linked publication.

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 31 Aug 2007.

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