Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Limb-threatening Ischemia Diabetes Mellitus

Keywords

Bone marrow mononuclear cellsMesenchymal stem cells

Outcome Measures

Primary Outcomes (10)

Safety profile: (adverse events (AEs) and serious AEs)
AEs: (i) local toxicity, including signs of local inflammation (swelling, warmth, impairment of function), worsening of ulcer, new ulcer, or hematomas after auto-BM-MNC or allo-WJ-MSCs administration. (ii) systemic toxicity as fever, allergies. (iii) maximum grade toxicity for tissue.
12 months
Safety profile
Serious AEs: hospitalization, malignancy, amputation, persistent or significant disability, or death.
12 months
Efficacy profile: Rutherford's classification
0 to 6
12 months
TcPO2
mmHg
12 months

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Placebo group (n=10), which consisted of 15 injections of 1 mL of vehicle (1 mL saline solution with 2% of autologous serum) on periadventitial arteries in one dose at day 0.

Biological: Cell-based therapy

Auto-BM-MNC

EXPERIMENTAL

Auto-BM-MNC (n=7) were obtained from diabetic patients. Fifteen injections of 7.197x106 ± 2.984x106 cells/mL each with 2% of autologous serum were periadventitial arteries administrated in one dose at day 0.

Biological: Cell-based therapy

Allo-WJ-MSCs

EXPERIMENTAL

Interventions

Cell-based therapyBiological

One dose of auto-BM-MNC, one dose of allo-WJ-MSCs, or one dose of placebo solution (saline solution with 2% of autologous serum), were periadventitial arteries administration in CTLI patients.

Allo-WJ-MSCsAuto-BM-MNCPlacebo group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult male or female, 40 years of age or over (until 85 years old)
TcPO2 ≤ 30 mmHg.

Sponsors & Collaborators

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Otherlead

Study Sites (1)

Fundación Oftalmológica de Santander (FOSCAL)

Bucaramanga, Colombia

Related Publications (1)

Arango-Rodriguez ML, Mateus LC, Sossa CL, Becerra-Bayona SM, Solarte-David VA, Ochoa Vera ME, Viviescas LTG, Berrio AMV, Serrano SE, Vargas O, Isla AC, Benitez A, Rangel G. A novel therapeutic management for diabetes patients with chronic limb-threatening ischemia: comparison of autologous bone marrow mononuclear cells versus allogenic Wharton jelly-derived mesenchymal stem cells. Stem Cell Res Ther. 2023 Aug 25;14(1):221. doi: 10.1186/s13287-023-03427-z.
PMID: 37626416DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaDiabetes Mellitus

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Martha L Arango, PhD
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director Technical and Scientific Centro de Terapias Avanzadas Fundación Ofalmológica de Santander (FOSCAL)

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 30, 2022

Study Start

January 1, 2019

Actual (reported)

Bone Marrow Mononuclear Cells vs Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb Ischemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (10)

Study Arms (3)

Placebo group

Auto-BM-MNC

Allo-WJ-MSCs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (10)

Study Arms (3)

Placebo group

Auto-BM-MNC

Allo-WJ-MSCs

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations