Administration of Adipose-derived Stem Cells (ASC) in Patient With Critical Limb Ischemia.

NCT03968198 | Terminated Phase 2 DMC

• 1 other identifier: RC31/14/7441
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Different types of stem cells have recently been studied in clinical trial on ischemic disease of the heart and muscular arteries. Adipose derived stem cell, have shown in vitro and in vivo models a stronger potential of success in recovering from ischemic disease and oxygenation of the tissues. The investigators already shown in a phase I study, that adipose derived mesenchymal cells injected in patients with critical limb ischemia and no option for revascularization, had a very good tolerance and interesting effects on skin oxygenation and healing. The aim of the present clinical trial is to confirm the efficacy autologous transplantation of adipose tissue derived mesenchymal cells in patients with critical limb ischemia with poor options or no option for revascularization.

Conditions

Critical Limb Ischemia and Peripheral Artery Disease

Keywords

Cell therapy; ASC autologous; CLI; PAD; No option

Outcome Measures

Primary Outcomes (2)

• Number of patients alive without major amputation

  Evaluation of the presence of rest pain or ischemic ulcer and ankle pressures less than 70 mmHg or toe systolic pressure less than 50 mmHg or TcPO2 of less than 30 mmHg, at six month.

  Between 1 and 6 months

• Number of patients alive without critical limb ischemia

  Evaluation of the presence of rest pain or ischemic ulcer and ankle pressures less than 70 mmHg or toe systolic pressure less than 50 mmHg or TcPO2 of less than 30 mmHg, at six month.

  Between 1 and 6 months

Secondary Outcomes (8)

• New vessels

  Between 1 and 6 months

• Blood flow

  Between 1 and 6 months

• Wound surface reduction

  Between 1 and 6 months

• Ulcer healing

  Between 1 and 6 months

• Pain reduction

  Between 1 and 6 months

Study Arms (1)

ASC (Adipose-derived Stem/Stroma Cells)

EXPERIMENTAL

Patients administrated with autologous ASC in their ischemic inferiors limbs

Drug: Autologous ASC (for Adipose-derived Stem/Stroma Cell)

Interventions

Autologous ASC (for Adipose-derived Stem/Stroma Cell) DRUG

After adipose tissue aspiration (liposuction) by an authorized person, ASCs were isolated and cultured during 14±2 days by the French Blood Establishment. Then, patients receive intramuscular injections of ASCs.

ASC (Adipose-derived Stem/Stroma Cells)

Eligibility Criteria

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

You may qualify if:

• Patients over 18 years old,
• Rest pain or ischemic ulcers /gangrene of the lower limb, present for at least 15 days, requiring analgesic absorption, with ankle pressures less than 70 mmHg or toe systolic pressure less than 50 mmHg or TcPO2 of less than 30 mmHg
• Patient with persistent CLI after revascularization will be included if :
• they have severe cardiac, respiratory or renal disease who are at increased risk of complication from surgery or anesthesia, e.g. moderately severe or severe heart failure (NYHA class III or IV), severe or very severe Chronic Obstructive Pulmonary disease or severe renal disease (creatinine clearance \<30 mL/minute).
• there is no option for endovascular or open surgery revascularization ; or poor option (defined by: need for an infra-popliteal by-pass without the availability of autologous great saphenous vein, need for use of great saphenous vein \<3 mm in diameter for tibial level bypass based on venous duplex ultrasound, or calcified or small (\<2 mm) distal target vessel, or open wound on the receiving site or infrapopliteal PAD)
• Patients who signed the informed consent,
• Patient affiliated to a social security system

You may not qualify if:

• History of cancer
• Need of a major amputation (amputation at or above the ankle) within 2 weeks,
• Ulcers with exposure of tendons, osteomyelitis, or clinically uncontrolled infection,
• TcPO2 \<10 mmHg at rest and \< 30 mmHg sitting with legs dependent (very poor vascular reserve),
• Patient under judicial protection,
• Pregnant women,
• Women of childbearing age without effective contraception.
• Refusal of the patient to participate in the study,
• Positive HIV-1 or 2, Human T Leukemia virus (HTLV)-1 or 2, Hepatite B Virus (HBV) (except vaccine profile), Syphilis (except inactive disease), or Hepatite C Virus (HCV)
• Patients necessitating drugs with inhibitory or stimulatory effect on the growth and multiplication of cells or drugs with immunosuppressive effect: Cyclosporine, Mycophenolate mofetil, Azathioprine, Tacrolimus (systemic), Anthracyclines, Neupogen or equivalent, Etanercept, Interferons, Corticoids at anti-inflammatory doses.
• No possibility of adipose tissue harvest and cell injection in the leg
• Another clinical trial participation (except non interventional studies),
• Patient under judicial protection,
• Pregnant and breastfeeding women,
• Women of childbearing age without effective contraception,

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Etablissement Français du Sang: collaborator

Study Sites (1)

Rangueil Hospital

Toulouse, 31059, France

Location

Related Publications (1)

• Dubsky M, Husakova J, Sojakova D, Fejfarova V, Jude EB. Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence? Mol Diagn Ther. 2023 Nov;27(6):673-683. doi: 10.1007/s40291-023-00667-w. Epub 2023 Sep 22.

  PMID: 37740111 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• BURA-RIVIERE Alessandra, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 30, 2019
• Study Start: March 4, 2020
• Primary Completion: March 10, 2023
• Study Completion: March 10, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)