Critical Limb Ischemia Clinical Trial
Official title:
A Non-randomized, Open Label, Multicentric, Dose Ranging , Phase II Study Assessing the Efficacy and Safety of Intramuscular Administration of Stempeucel - CLIâ„¢ (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With Critical Limb Ischemia Due to Buerger's Disease
Verified date | September 2016 |
Source | Stempeutics Research Pvt Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Drugs Controller General of India |
Study type | Interventional |
This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.
Status | Completed |
Enrollment | 90 |
Est. completion date | March 2016 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Buerger's disease as diagnosed by Shionoya criteria - Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs - Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5 - Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (Patients with wet gangrene must undergo wound debridement / amputation before screening) - Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) - Ankle Brachial Pressure Index (ABPI) = 0.6 or ankle pressure = 50 mm Hg or TcPO2 = 40 mmHg in the foot of the study limb - Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent and video consent, abide by the study requirements, and agree to return for required follow-up visits Exclusion Criteria: - Patients with CLI indicated for major amputation during screening - Atherosclerotic PAD - Ulcers with exposure of tendon and/bone in the shin region - Previous above transmetatarsal amputation in study limb - Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening - Patients with gait disturbance for reasons other than CLI - Diagnosis of diabetes mellitus (type 1 or type 2) - Patients having left ventricular ejection fraction < 35% - Patients suffering from clinically relevant peripheral neuropathy - History of Stroke or myocardial infarction - Patients who are contraindicated for MRA - Patients with deep vein thrombosis in any limb - Patients who have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy - Documented terminal illness or cancer or any concomitant disease process with a life expectancy of <1 year - Patients already enrolled in another investigational drug trial or completed within 3 months or those who have participated in any stem cell clinical trial - Patient with known hypersensitivity to the constituents of the IMP - dimethyl sulfoxide (DMSO) or human serum albumin (HSA) - History of severe alcohol or drug abuse within 3 months of screening - Hb% < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine = 2mg%, serum Total Bilirubin =2mg% - Pregnant and lactating women - Patients tested positive for HIV 1, HCV, HBV, CMV, RPR |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals | Bangalore | Karnataka |
India | Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research | Bangalore | Karnataka |
India | Department of Vascular Surgery, Madras Medical College | Chennai | Tamil Nadu |
India | Department of Vascular Surgery, Sri Ramchandra Medical College | Chennai | Tamil Nadu |
India | Department of Vascular Surgery, Stanley Medical College | Chennai | Tamil Nadu |
India | Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity | Gurgaon | Haryana |
India | Department of Vascular Surgery, AMRI Hospital | Kolkata | West Bengal |
India | Nightingale Hospital | Kolkata | West Bengal |
India | Department of Surgery, KMC, Mangalore | Mangalore | Karnataka |
India | Department of Surgical Disciplines, All India Institute of Medical Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Stempeutics Research Pvt Ltd |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relief of the rest pain | Rest pain will be measured using rest pain scale (0 to10) | 6 months | No |
Primary | Healing of ulcerations or reduction of ulcer area in the target limb | Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size. | 6 months | No |
Primary | Relief of the rest pain | Rest pain will be measured using rest pain scale (0 to 10) | 24 months | No |
Primary | Healing of ulcerations or reduction of ulcer area in the target limb | Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size. | 24 months | No |
Secondary | Pain free walking distance | 6 and 24 months | No | |
Secondary | Major amputation free survival | 6 and 24 months | No | |
Secondary | Ankle brachial pressure index (ABPI) - measured by Doppler | 6 and 24 months | No | |
Secondary | Increase in transcutaneous partial oxygen pressure (TcPO2) | 6 and 24 months | No | |
Secondary | Quality of life by King's College VascuQOL questionnaire | 6 and 24 months | No | |
Secondary | Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) | 6 and 24 months | No | |
Secondary | The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). | 6 and 24 months | Yes | |
Secondary | Assessment of clinical laboratory parameters | 6 and 24 months | Yes | |
Secondary | Physical examination findings and assessment of vital signs | 6 and 24 months | Yes | |
Secondary | Assessment of electrocardiogram (ECG) parameters | 6 and 24 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03668353 -
Recombinant SeV-hFGF2/dF Injection for PAOD
|
Phase 1 | |
Recruiting |
NCT04110964 -
Evaluation of Safety and Tolerability of Libella Gene Therapy for Critical Limb Ischemia: AAV- hTERT
|
Phase 1 | |
Not yet recruiting |
NCT03994666 -
Cell Therapy in Critical Limb Ischemia
|
Phase 2 | |
Recruiting |
NCT02389023 -
Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery
|
N/A | |
Completed |
NCT02539940 -
Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
|
||
Not yet recruiting |
NCT02498080 -
Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia
|
N/A | |
Recruiting |
NCT02239419 -
Evaluation of Carbothera in the Treatment of Foot Ulcers
|
N/A | |
Recruiting |
NCT01938872 -
Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia
|
N/A | |
Active, not recruiting |
NCT01211925 -
Distal Venous Arterialisation of Ischemic Limb
|
Phase 2/Phase 3 | |
Completed |
NCT02454231 -
Monocentric Trial: Stem Cell Emergency Life Threatening Limbs Arteriopathy (SCELTA)
|
Phase 2/Phase 3 | |
Completed |
NCT01758874 -
Study to Explore the Effect of Lowering Blood Viscosity in Patients With Treatment-resistant Critical Limb Ischemia
|
Phase 2 | |
Completed |
NCT02475200 -
Phoenix Post-Approval Registry - Using the Phoenix Atherectomy Systems
|
||
Recruiting |
NCT04583436 -
Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia
|
N/A | |
Completed |
NCT04071782 -
Investigating the Safety and Efficacy of the Treatment With the Selution Sirolimus Coated Balloon in TASC C and D Tibial Occlusive Disease in Patients With Critical Limb Ischemia From Singapore
|
N/A | |
Completed |
NCT03669458 -
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
|
N/A | |
Not yet recruiting |
NCT06007469 -
Pedal Acceleration Time (PAT) as a Measure of Foot Perfusion
|
||
Recruiting |
NCT04110327 -
An All-Comers Observational Study of the MicroStentâ„¢ Peripheral Vascular Stent System in Subjects With Peripheral Arterial Disease
|
||
Completed |
NCT02260622 -
Pilot Study to Examine the Use of Rivaroxaban After Angioplasty for Critical Limb Ischemia
|
Phase 2 | |
Recruiting |
NCT02054416 -
External Compression Therapy for Secondary Prevention of Lower-Limb Loss and Cardiovascular Mortality
|
N/A |