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Mesenchymal stem cells from adipose tissue

Phase 2

Critical Limb Ischemia | Unknown | Cardiovascular |Design Therapeutics, Inc.|Last Updated: Jul 9, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

Mesenchymal stem cells from adipose tissue · 1 trial · 1 indication

Phase 2 1
NCT01745744Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.Critical Limb Ischemia
COMPLETED33 Analytics
PHASE2COMPLETED
Application of Cell Regeneration Therapy With Mesenchymal Stem Cells From Adipose Tissue in Critical Chronic Ischemic Syndrome of Lower Limbs (CLI) in Nondiabetic Patients.
Critical Limb IschemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events and serious adverse events
12 months.

Number of adverse events and serious adverse events: 24h administration of CeTMAd, 1 month, 3 months, 6 months, 9 months and 12 months.

Secondary Endpoints

Evolution of chronic critical ischemia
1 month, 3 months, 6 months, 9 months and 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low doseEXPERIMENTAL\- Infusion of mesenchymal stem cells from adipose tissue: 0.5x106 cells / kg of patient weight.
High doseEXPERIMENTAL\- Infusion of mesenchymal stem cells from adipose tissue: 1x106 cells / kg of patient weight.
ControlNO_INTERVENTIONConventional treatment

Interventions

NameTypeDescription
Mesenchymal stem cells from adipose tissueOTHER\- Infusion of mesenchymal stem cells from adipose tissue administered intraarterially: 0.5x106 cells / kg of patient weight and 1x106 cells / kg of patient weight.
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Eligibility Criteria

Age Range18 Years to 89 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients of both sexes aged ≥ 18 and ≤ 89 years. * Nondiabetic. * Infrapopliteal atherosclerotic vascular disease of severe grade with either severe claudication or Rutherford-Becker grade II-III-IV, of at least one lower limb. It is defined critical ischemia of the lower limb...

Countries:Spain
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Frequently asked questions about Mesenchymal stem cells from adipose tissue

What is Mesenchymal stem cells from adipose tissue used for?

Mesenchymal stem cells from adipose tissue is an investigational cell therapy being studied for Critical Limb Ischemia, a severe form of peripheral artery disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who is developing Mesenchymal stem cells from adipose tissue?

Design Therapeutics, Inc. (NASDAQ: DSGN) is the developer of Mesenchymal stem cells from adipose tissue. The company is conducting clinical research on this cell therapy for the treatment of Critical Limb Ischemia.

What phase is Mesenchymal stem cells from adipose tissue in?

Mesenchymal stem cells from adipose tissue is in Phase 2 clinical development. It is an investigational therapy and has not received regulatory approval. One Phase 2 trial has been completed, with results not yet reported in this context.

What clinical trials is Mesenchymal stem cells from adipose tissue in?

Mesenchymal stem cells from adipose tissue has one completed Phase 2 trial, NCT01745744, which enrolled 33 patients with Critical Limb Ischemia in Spain. The trial was randomized and controlled with no treatment, and it included biomarker selection.

Is Mesenchymal stem cells from adipose tissue the same as stem cell therapy for CLI?

Mesenchymal stem cells from adipose tissue is a specific type of stem cell therapy derived from fat tissue, being tested for Critical Limb Ischemia. It is distinct from other stem cell sources, such as bone marrow-derived cells, and is being evaluated in clinical trials.