Critical Limb Ischemia and Peripheral Artery Disease Clinical Trial
— ACellDREAM2Official title:
Autologous Transplantation of Adipose Tissue Derived Mesenchymal Stroma/Stem Cells (ASC) in Patients With Critical Limb Ischemia.
| Verified date | March 2023 |
| Source | University Hospital, Toulouse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | March 10, 2023 |
| Est. primary completion date | March 10, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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 : 1. 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). OR 2. 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 Exclusion Criteria: - 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, - Lack in understanding the nature and aims of the study and/or difficulties in communication with the investigator. |
| Country | Name | City | State |
|---|---|---|---|
| France | Rangueil Hospital | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Toulouse | Etablissement Français du Sang, Institut National de la Santé Et de la Recherche Médicale, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | New vessels | Blind evaluation of the number of new vessels in the treated limb by standardized angiographic magnetic resonance | Between 1 and 6 months | |
| Secondary | Blood flow | Evaluation of the blood flow by laser Doppler, transcutaneous pressure of oxygen (TcPO2), ankle pressure. | Between 1 and 6 months | |
| Secondary | Wound surface reduction | Percentage reduction of wound surface (standardized layer measurement). | Between 1 and 6 months | |
| Secondary | Ulcer healing | Evaluation of percentage of complete ulcer healing. | Between 1 and 6 months | |
| Secondary | Pain reduction | Evaluation of pain reduction by standardized evaluation (visual scale and drug consumption).
The visual scale is in a form of plastic ruler and measures the intensity of pain on a scale ranging from 0 (no pain) to 10 (maximum pain). |
Between 1 and 6 months | |
| Secondary | Wound infection | Percentage of wound infection and irritative dermatitis (expected adverse events) | Between 1 and 6 months | |
| Secondary | Immuno measures in blood sample | interleukin-1, interleukin-2, interleukin-4, interleukin-6, interleukin-10, interleukin-12, Tumor Necrosis Factor alpha (TNFa), will be measured out in blood samples. | Between 1 and 6 months | |
| Secondary | Immuno measures in vitro | Mesenchymal stem cells (MSC) trophic factors and immune- modulators (Hepatocyte growth factor (HGF), Vascular Endothelial Growth Factor (VEGF), indoleamine 2, 3-dioxygenase (IDO), Human Leucocyte Antigen G (HLA-G)) will be studied in vitro. | Between 1 and 6 months |