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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01257776

Enrollment

Registered

2010-12-10

Start date

2010-12-31

Completion date

2015-07-31

Last updated

2015-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia (CLI), Diabetes

Keywords

Critical Limb Ischemia (CLI), Diabetes, Mesenchymal Stem Cells, Regenerative Therapy

Brief 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)

Interventions

DRUGAutologous adipose derived mesenchymal stem cells

Intra-arterial administration through a selective cannulation of target common femoral artery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Ankle Brachial Index	1 month, 6 months, 12 months
University of Texas Classification at target limb	1 month, 6 months, 12 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026