Human Adipose Derived Mesenchymal Stem Cells for Critical Limb Ischemia (CLI) in Diabetic Patients

Diabetes Clinical Trial

Official title:

Using Mesenchymal Stem Cells From Adipose Tissue (CeTMAd) as Cell Regeneration Therapy in Chronic Ischemic Syndrome of Lower Limbs in Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257776
• Other study ID #: CeTMAd/ICPD/2008
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 9, 2010
• Last updated: August 4, 2015
• Start date: December 2010
• Est. completion date: July 2015

Study information

• Verified date: November 2014
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

A prospective, multicenter, open, randomized, parallel-group controlled study for two levels of dose.

The study population will consist of 30 non-diabetic patients with critical chronic ischemia in at least one of the lower limbs (CLI) and without possibility of revascularization, from whom results can clinically be evaluable, of whom, 20 patients will be included in the experimental group (10 for each dose level) and 10 in the control group.

In each of the two dose levels to be used in the study, 15 patients will be included, who will be randomized to the experimental group or the control group according to a distribution 2:1 (2 patients in the experimental group and 1 in control group), thus at each dose level, we will have 10 patients in the experimental group (treated with mesenchymal cells of adipose tissue) and 5 patients in the control group (conventional treatment)

Other known NCT identifiers

• NCT01079403

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia (CLI)
• Diabetes
• Ischemia

Intervention

Drug:
• Autologous adipose derived mesenchymal stem cells
Intra-arterial administration through a selective cannulation of target common femoral artery

Locations

Country	Name	City	State
Spain	CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)	Seville
Spain	University Hospital Virgen Macarena	Seville

Sponsors (2)

Lead Sponsor	Collaborator
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud	Iniciativa Andaluza en Terapias Avanzadas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic assessment of neovasculogenesis (angiogenesis plus arteriogenesis)	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.	6 months	No
Primary	Major adverse event (death, target limb amputation)		1 month, 6 months, 12 months	Yes
Secondary	Ankle Brachial Index		1 month, 6 months, 12 months	No
Secondary	University of Texas Classification at target limb		1 month, 6 months, 12 months	Yes