A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease

Stempeutics

Status and phase

Withdrawn

Phase 2

Conditions

Critical Limb Ischemia Due to Buerger's Disease

Treatments

Biological: Stempeucel(R)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03056742

SRPL/CLI/10-11/001 Version 4

Details and patient eligibility

About

This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC).

Full description

This study will evaluate the safety and efficacy of intramuscular injection of stempeucel(R) (Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in Critical Limb Ischemia due to Buerger's Disease

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) .
ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
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 trans metatarsal 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 DVT 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 received stem cells in the past
Patient with known hypersensitivity to the constituents of the stempeucel®- 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 & 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen