Recent Updates
Recently added Catalysts

Autologous adipose derived mesenchymal stem cells

Phase 1

Critical Limb Ischemia (CLI) | Small molecule | Metabolic |Design Therapeutics, Inc.|Last Updated: Aug 5, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01257776Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic PatientsPHASE1 COMPLETED 33 — — Dec 1, 2010Jul 1, 2015Aug 5, 20152 Spain
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)
6 months

Target limb vascularization would be quantified by a dedicated software, MetaMorph® v.6.3, by using Angiogenesis Tube Formation application module. Neovasculogenesis would be the difference between vascularization at baseline and 6 months follow-up.

Major adverse event (death, target limb amputation)
1 month, 6 months, 12 months
Secondary Endpoints
Ankle Brachial Index
1 month, 6 months, 12 months
University of Texas Classification at target limb
1 month, 6 months, 12 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mesenchymal stem cells 0,5 million * weight (kg)ACTIVE_COMPARATORGroup of low dose of Mesenchymal stem cells.
Mesenchymal stem cells 1 million * weight (kg)ACTIVE_COMPARATORGroup of mid dose of mesenchymal stem cells
Controlled groupNO_INTERVENTIONControlled group with no intervention
Interventions
NameTypeDescription
Autologous adipose derived mesenchymal stem cellsDRUGIntra-arterial administration through a selective cannulation of target common femoral artery
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Diabetes, type 1 or 2 * Critical Limb Ischemia (Rutherford Becker Class II,III or IV)of at least one limb. * No options for target limb revascularization. Exclusion Criteria: * Cancer antecedent in the last two years * Current limb infection or limb gangrene

Countries:Spain
Unlock Eligibility Criteria