Critical Limb Ischemia Due to Buerger's Disease Clinical Trial
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
| Verified date | April 2017 |
| Source | Stempeutics Research Pvt Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2019 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals | 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 | Saveetha Medical College & Hospital | Chennai | Tamil Nadu |
| India | SRM Medical College Hospital and Research Centre | Chennai | Tamil Nadu |
| India | Health Point Hospital | Kolkata | West Bengal |
| India | Nightingale Hospital | Kolkata | West Bengal |
| 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 |
|---|---|---|---|---|
| Other | The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). | 6 months and 24 months | ||
| Other | CVS mortality | 6 months and 24 months | ||
| Other | All-cause mortality | 6 months and 24 months | ||
| Primary | Relief of the rest pain | 6 months | ||
| Primary | Reduction of ulcer area in the target limb | 6 months | ||
| Secondary | Total walking distance | 6 months and 24 months | ||
| Secondary | Major amputation free survival | 6 months and 24 months | ||
| Secondary | Ankle brachial pressure index (ABPI) - measured by Doppler | 6 months and 24 months | ||
| Secondary | Quality of life (QOL) by King's College VascuQOL questionnaire | 6 months and 24 months | ||
| Secondary | Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) | 6 months and 24 months |