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

NCT01257776 | Completed Phase 1 DMC

• 1 other identifier: CeTMAd/ICPD/2008
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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)

Conditions

Critical Limb Ischemia (CLI); Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Major adverse event (death, target limb amputation)

  1 month, 6 months, 12 months

Secondary Outcomes (2)

• Ankle Brachial Index

  1 month, 6 months, 12 months

• University of Texas Classification at target limb

  1 month, 6 months, 12 months

Study Arms (3)

Mesenchymal stem cells 0,5 million * weight (kg)

ACTIVE COMPARATOR

Group of low dose of Mesenchymal stem cells.

Drug: Autologous adipose derived mesenchymal stem cells

Mesenchymal stem cells 1 million * weight (kg)

ACTIVE COMPARATOR

Group of mid dose of mesenchymal stem cells

Drug: Autologous adipose derived mesenchymal stem cells

Controlled group

NO INTERVENTION

Controlled group with no intervention

Interventions

Autologous adipose derived mesenchymal stem cells DRUG

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

Mesenchymal stem cells 0,5 million * weight (kg); Mesenchymal stem cells 1 million * weight (kg)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cancer antecedent in the last two years
• Current limb infection or limb gangrene

Sponsors & Collaborators

• Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud: lead
• Iniciativa Andaluza en Terapias Avanzadas: collaborator

Study Sites (2)

University Hospital Virgen Macarena

Seville, Seville, 41007, Spain

Location

CABIMER (Andalusian Center for Molecular Biology and Regenerative Medicine)

Seville, Seville, 41092, Spain

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rafael J Ruiz-Salmeron, MD, PhD

  University Hospital Virgen Macarena. Seville.Spain

  PRINCIPAL INVESTIGATOR

• Antonio De la Cuesta, MD

  University Hospital Virgen Macarena. Seville.Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2015
• Last Updated: August 5, 2015

Record last verified: 2014-11

Locations

ES (2)