Clinical trial NCT03056742: A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
Official title: A Single Arm, Open Label, Multicentric, Clinical Study Assessing the Efficacy and Safety of Stempeucel® (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With CLI Due to Buerger's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Critical Limb Ischemia Due to Buerger's Disease
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
First posted: 2017-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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

Eligibility criteria: Inclusion Criteria:

1. Buerger's disease as diagnosed by Shionoya criteria
2. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
3. Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
4. 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) .
5. 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) .
6. ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
7. 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:

1. Patients with CLI indicated for major amputation during screening
2. Atherosclerotic PAD
3. Ulcers with exposure of tendon and/bone in the shin region.
4. Previous above trans metatarsal amputation in study limb
5. Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
6. Patients with gait disturbance for reasons other than CLI
7. Diagnosis of diabetes mellitus (type 1 or type 2)
8. Patients having left ventricular ejection fraction \< 35%
9. Patients suffering from clinically relevant peripheral neuropathy
10. History of stroke or myocardial infarction
11. Patients who are contraindicated for MRA
12. Patients with DVT in any limb.
13. 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
14. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of \<1 year
15. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past
16. Patient with known hypersensitivity to the constituents of the stempeucel®- dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
17. History of severe alcohol or drug abuse within 3 months of screening
18. Hb% \< 10 gm% for males, Hb% \< 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%
19. Pregnant and lactating women
20. Patients tested positive for HIV 1 \& 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen

Primary outcomes:
measure: Relief of the rest pain
timeFrame: 6 months
measure: Reduction of ulcer area in the target limb
timeFrame: 6 months
Secondary outcomes:
measure: Total walking distance
timeFrame: 6 months and 24 months
measure: Major amputation free survival
timeFrame: 6 months and 24 months
measure: Ankle brachial pressure index (ABPI) - measured by Doppler
timeFrame: 6 months and 24 months
measure: Quality of life (QOL) by King's College VascuQOL questionnaire
timeFrame: 6 months and 24 months
measure: Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
timeFrame: 6 months and 24 months
Other outcomes:
measure: The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
timeFrame: 6 months and 24 months
measure: CVS mortality
timeFrame: 6 months and 24 months
measure: All-cause mortality
timeFrame: 6 months and 24 months
Locations:
city: New Delhi
country: India
facility: Department of Surgical Disciplines, All India Institute of Medical Sciences
state: Delhi
city: Bangalore
country: India
facility: Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
state: Karnataka
city: Chennai
country: India
facility: Department of Vascular Surgery, Madras Medical College
state: Tamil Nadu
city: Chennai
country: India
facility: Department of Vascular Surgery, Sri Ramchandra Medical College
state: Tamil Nadu
city: Chennai
country: India
facility: Saveetha Medical College & Hospital
state: Tamil Nadu
city: Chennai
country: India
facility: SRM Medical College Hospital and Research Centre
state: Tamil Nadu
city: Kolkata
country: India
facility: Health Point Hospital
state: West Bengal
city: Kolkata
country: India
facility: Nightingale Hospital
state: West Bengal
Study officials:
References: