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Chronic Limb-threatening IschemiaPhase 1/2NCT05631444

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

A Phase 1/2 study testing Cell-based therapy in people with Chronic Limb-threatening Ischemia and Diabetes Mellitus, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden. There is an urgent need to develop an effective therapeutic strategy to treat this disease. Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
Cell-based therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteColombia
Study dates
1 Jan 2019to 28 Oct 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female, 40 years of age or over (until 85 years old)
  • TcPO2 ≤ 30 mmHg.
  • Diagnosis of diabetes.
  • Patients with signs of critical ischemia such as (i) ulcer that does not heal, (ii) necrosis or loss of tissue, (iii) pain at rest, and (iv) intermittent claudication.
  • Basal Rutherford classification stage 3 to 5.
  • Non-revascularizable patients due to comorbidities and/or anatomy.
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  • Patients that despite revascularization (vascular surgery), have adequate distal beds to perfuse the limb.
  • Ankle/brachial index less than 0.4.
  • Stenosis or occlusion of the infrapatellar arteries.

Who cannot join

  • Participants that do not sign the informed consent.
  • Presence of osteomyelitis.
  • Hemodynamic instability (MAP<65 mmHg or vasopressor requirement).
  • Any acute systemic infectious disease process.
  • Severe sepsis.
  • Uncontrolled coagulopathy.
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  • Condition of cancer.
  • Use of immunosuppressive or cytotoxic drugs
  • Alterations of the bone marrow that do not allow the adequate extraction of the components to be used as: acute leukemia, chronic leukemia, marrow aplasia, myelodysplastic syndrome, and myelophthisis.
  • Contraindication of sedation for bone marrow aspirate.
  • Patients who have suffered in a period < six months of myocardial infarction, disease cerebrovascular or coronary intervention.
  • Patients with liver failure indicated by serum transaminases (aspartate aminotransferase and alanine aminotransferase), with values twice the normal limit.
  • Any acute or chronic contagious disease including hepatitis B, hepatitis C, and HIV.
  • Any other comorbidity that the treating vascular surgeon considers as a contraindication to cell treatments.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

  • Fundación Oftalmológica de Santander (FOSCAL)

    Bucaramanga

Other trials in Colombia

About this study

Official title: Comparison of the Therapeutic Potential of Autologous Bone Marrow Mononuclear Cells Versus Allogenic Wharton Jelly-derived Mesenchymal Stem Cells in Diabetic Patients With Chronic Limb-threatening Ischemia

Patients in the severe stages of Chronic limb-threatening ischemia (CLTI) are prone to amputation and death, leading to poor quality of life and a great socioeconomic burden.

There is an urgent need to develop an effective therapeutic strategy to treat this disease. In this context, autologous bone marrow mononuclear cells (BM-MNC) and allogeneic mesenchymal stem cells derived from different sources have emerged as promising therapeutic approaches for this condition.

Read the detailed description

Comparison of the therapeutic potential of BM-MNC vs. allogeneic Wharton jelly-derived mesenchymal stem cells (allo-WJ-MSCs) in diabetic patients with CLTI.

Twenty-four type 2 diabetic patients in the most severe stages of the CLTI (category 4 or 5 in Rutherford's classification and transcutaneous oxygen pressure (TcPO2) below 30 mm Hg were enrolled and randomized to receive 15 injections of (i) BM-MNC (7.197x106 ± 2.984 x106 cells/mL each with 2% of autologous serum) (n=7), (ii) allo-WJ-MSCs (1.333 x106 cells/mL each with 5% of human serum albumin serum) (n=7) or (iii) placebo solution (1 mL saline solution with 2% of autologous serum) (n=10), which were administered into the periadventitial arteries.

The follow-up visits were at months 1, 3, 6, and 12, to evaluate the following parameters:

(i) Rutherford classification (0 to 6) (ii) TcPO2 (mmHg) (iii) Wound closure (area cm2) (iv) pain (visual analogue scale (0-10) (v) pain-free walking distance (m) (vi) revascularization and limb-survival proportion during follow-up (vii) the quality of life (EQ-5D questionnaire).

Being tested
Cell-based therapy
Keywords
Bone marrow mononuclear cells, Mesenchymal stem cells
Medical subject headings
Chronic Limb-Threatening Ischemia, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05631444
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorPlacebo 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.
Receives: Biological: Cell-based therapy
Auto-BM-MNCExperimentalAuto-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.
Receives: Biological: Cell-based therapy
Allo-WJ-MSCsExperimentalAllo-WJ-MSCs (n=7) were obtained from culturing the WJ from healthy cordon umbilical donors unrelated to the patient. Fifteen injections of 1.333x106 cells/mL each with 5% of human serum albumin serum were periadventitial arteries administrated in one dose at day 0.
Receives: Biological: Cell-based therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. Safety profile

    Serious AEs: hospitalization, malignancy, amputation, persistent or significant disability, or death.

    Measured: 12 months

  3. Efficacy profile: Rutherford's classification

    0 to 6

    Measured: 12 months

  4. TcPO2

    mmHg

    Measured: 12 months

  5. Efficacy profile: Visual Analogue Scale pain

    0 to10

    Measured: 12 months

  6. Efficacy profile: Pain-free walking distance

    meters

    Measured: 12 months

  7. Efficacy profile: Wound closure

    cm2

    Measured: 12 months

  8. Efficacy profile: Revascularization

    Percentage

    Measured: 12 months

  9. Efficacy profile: Limb survival proportion

    Percentage

    Measured: 12 months

  10. Efficacy profile: Quality of life

    EQ-5D questionnaire

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start1 Jan 2019
  3. Primary completion30 Sep 2020
  4. Study completion28 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05631444
Sponsor's protocol ID
CLTI 01
Status last verified
Nov 2022
First submitted
30 Oct 2022
Last updated
30 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37626416

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cell-based therapy in people with Chronic Limb-threatening Ischemia and Diabetes Mellitus, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety profile: (adverse events (AEs) and serious AEs) (time frame: 12 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05631444, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.

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