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CD34-positive cells

Phase 1

Peripheral Artery Disease | Monoclonal antibody | Cardiovascular |Baxter International Inc.|Last Updated: Jul 25, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

CD34-positive cells · 1 trial · 3 indications

Phase 1 1
NCT00616980Injection of Autologous CD34-Positive Cells for Critical Limb IschemiaPeripheral Artery Disease
COMPLETED28 Analytics
PHASE1COMPLETED
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
Peripheral Artery DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety of Intramuscular Injection of CD34-positive cells
6 months and 1 year
Change in Rest Pain
6 months
Ulcer Healing
6 months
Functional Improvement
6 months
Limb Salvage
6 months

Secondary Endpoints

Disease Severity
6 months
Assessment of Co-morbidity
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low DoseACTIVE_COMPARATOR -
High DoseACTIVE_COMPARATOR -
SalinePLACEBO_COMPARATOR -

Interventions

NameTypeDescription
CD34-positive cellsBIOLOGICAL -
Saline and 5% autologous plasmaBIOLOGICAL -
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Eligibility Criteria

Age Range21 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * 21-80 years of age * moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5) * unsuitable for conventional revascularization Exclusion Criteria: * advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or g...

Countries:United States
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Frequently asked questions about CD34-positive cells

What is CD34-positive cells used for?

CD34-positive cells are an investigational cell therapy being studied for the treatment of Peripheral Artery Disease, specifically critical limb ischemia, a severe form of peripheral vascular disease. The therapy involves injecting autologous CD34-positive cells into patients to potentially improve blood flow in affected limbs.

What does CD34-positive cells target?

CD34-positive cells are a cell-based therapy, not a molecularly targeted drug. The treatment uses a patient's own CD34-positive stem cells, which are believed to promote angiogenesis and tissue repair in ischemic limbs affected by Peripheral Artery Disease. The exact mechanism of action is under investigation.

Who makes CD34-positive cells?

CD34-positive cells are being developed by Baxter International Inc., a company publicly traded under the ticker symbol BAX. The therapy is an autologous cell product, meaning it is derived from the patient's own cells and then reinjected to treat Peripheral Artery Disease.

What phase is CD34-positive cells in?

CD34-positive cells are in Phase 1 clinical development for Peripheral Artery Disease. The therapy is investigational and has not been approved by regulatory authorities. A Phase 1 trial has been completed, but the product remains in early-stage clinical testing.

What clinical trials is CD34-positive cells in?

CD34-positive cells have been studied in one completed Phase 1 clinical trial, identified as NCT00616980, titled 'Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia.' The trial enrolled 28 participants in the United States and was a randomized, double-blind, placebo-controlled study.

Is CD34-positive cells the same as autologous CD34-positive cells?

Yes, CD34-positive cells refer to the same therapy as autologous CD34-positive cells. The investigational treatment uses a patient's own CD34-positive cells, which are collected and reinjected to treat Peripheral Artery Disease. The clinical trial NCT00616980 specifically evaluated this autologous cell therapy.