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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Single intramuscular administration of low dose of stem cells
Single intramuscular administration of intermediate dose of stem cells
Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity
Gurgaon, Haryana, 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
Relief of the rest pain
Rest pain will be measured using rest pain scale (0 to10)
Time frame: 6 months
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.
Time frame: 6 months
Relief of the rest pain
Rest pain will be measured using rest pain scale (0 to 10)
Time frame: 24 months
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.
Time frame: 24 months
Pain free walking distance
Time frame: 6 and 24 months
Major amputation free survival
Time frame: 6 and 24 months
Ankle brachial pressure index (ABPI) - measured by Doppler
Time frame: 6 and 24 months
Increase in transcutaneous partial oxygen pressure (TcPO2)
Time frame: 6 and 24 months
Quality of life by King's College VascuQOL questionnaire
Time frame: 6 and 24 months
Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bangalore, Karnataka, India
Department of Surgery, KMC, Mangalore
Mangalore, Karnataka, India
Department of Surgical Disciplines, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 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
Department of Vascular Surgery, AMRI Hospital
Kolkata, West Bengal, India
Nightingale Hospital
Kolkata, West Bengal, India
Time frame: 6 and 24 months
The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
Time frame: 6 and 24 months
Assessment of clinical laboratory parameters
Time frame: 6 and 24 months
Physical examination findings and assessment of vital signs
Time frame: 6 and 24 months
Assessment of electrocardiogram (ECG) parameters
Time frame: 6 and 24 months