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Autologous Bone Marrow Mononuclear Cells

Phase 1

Peripheral Vascular Diseases | Unknown | Cardiovascular |Design Therapeutics, Inc.|Last Updated: Nov 14, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Autologous Bone Marrow Mononuclear Cells · 1 trial · 2 indications

Phase 1 1
NCT00872326Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb IschemiaPeripheral Vascular Diseases
COMPLETED20 Analytics
PHASE1COMPLETED
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Peripheral Vascular DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Angiographic evaluation of angiogenesis and vasculogenesis at target limb
3 months

Secondary Endpoints

Ankle-Brachial pressure index
3 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Autologous Bone Marrow Mononuclear CellsEXPERIMENTALConsecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells

Interventions

NameTypeDescription
Autologous Bone Marrow Mononuclear CellsPROCEDUREInfusion \> 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diabetic patients under treatment (type I or II) * Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8) * Not suitable to be revascularized (surgical and interventional consensus) Exclusion Criteri...

Countries:Spain
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Frequently asked questions about Autologous Bone Marrow Mononuclear Cells

What is Autologous Bone Marrow Mononuclear Cells used for?

Autologous Bone Marrow Mononuclear Cells is an investigational cell therapy being studied for peripheral vascular diseases, specifically in diabetic patients with critical limb ischemia. It is currently in Phase 1 clinical development and is not approved by the FDA.

Who is developing Autologous Bone Marrow Mononuclear Cells?

Autologous Bone Marrow Mononuclear Cells is being developed by Design Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DSGN. The therapy is in Phase 1 clinical trials for peripheral vascular diseases.

What phase is Autologous Bone Marrow Mononuclear Cells in?

Autologous Bone Marrow Mononuclear Cells is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the therapy remains under investigation for peripheral vascular diseases.

What clinical trials is Autologous Bone Marrow Mononuclear Cells in?

Autologous Bone Marrow Mononuclear Cells has one completed clinical trial, NCT00872326, titled 'Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia.' This Phase 1 study enrolled 20 participants in Spain and was not randomized or blinded.

Is Autologous Bone Marrow Mononuclear Cells the same as bone marrow-derived mononuclear cells?

Yes, Autologous Bone Marrow Mononuclear Cells is also referred to as autologous bone marrow derived mononuclear cells. The clinical trial NCT00872326 uses this alternative name in its title, confirming they refer to the same investigational cell therapy.