An Open Labeled, Single-center, Phase I Study Assessing the Safety and Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia
Overview
- Phase
- Phase 1
- Intervention
- Cellgram-CLI
- Conditions
- Critical Limb Ischemia
- Sponsor
- Pharmicell Co., Ltd.
- Primary Endpoint
- Ankle Brachial Pressure Index, ABPI
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.
Detailed Description
If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability. A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group). Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection. Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age from 20 to 80 years
- •Patients with resting pain or ulceration of limb (Rutherford's class: II-4, III-5 or III-6)
- •Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or TCPO2 ≤ 60mmHg in the foot
- •Patients who were unsuitability for percutaneous transluminal angioplasty or a bypass operation
- •Patients who are not expected other treatments for at least 6 months
- •Patients who can agree to participate in the clinical trial by oneself or by one's legal representative
- •Patients who can conduct the clinical trial according to the protocol
Exclusion Criteria
- •Buerger's disease
- •History of hematologic disease
- •Patients who are at risk of embolism due to atrial fibrillation
- •Primary hematologic disease, including hypercoagulable states
- •Entrapment syndrome
- •Patients with osteomyelitis
- •Patients whose blood serum AST(Aspartate transaminase)/ALT(Alanine Transaminase) rates are more than three times the normal maximum rate, or whose creatinine rates are more than 1.5 times the normal maximum rate
- •Patients with history of anaphylaxis to gentamicin
- •Patients with hypersensitivity of bovine-derived ingredients
- •Patients with chronic heart failure, Glomerular disease and Obstructive pulmonary disease
Arms & Interventions
2-time injection group : Cellgram-CLI
Within 30 days after extracting bone marrow, autologous bone marrow-derived mesenchymal stem cells is directly injected into the lesion. Then the second cell is injected within 30 days after the first cell injection.
Intervention: Cellgram-CLI
Outcomes
Primary Outcomes
Ankle Brachial Pressure Index, ABPI
Time Frame: 6 months after BM-MSC therapy
Use Student's paired t-test or Wilcoxon's signed rank test to compare the difference of between the two visits(Screening and 6 month post treatment) before and after treatment.
Secondary Outcomes
- Collateral vessel formation on digital subtraction angiography (DSA)(6 months after BM-MSC therapy)
- Difference of Wound size(6 months after BM-MSC therapy)
- Improved transcutaneous oxygen pressure (TCPO2)(6 months after BM-MSC therapy)
- Pain on the Visual Analogue Scale(VAS)(6 months after BM-MSC therapy)
- Reduced limb amputation(6 months after BM-MSC therapy)
- Temperature change on thermography(6 months after BM-MSC therapy)
- Dose about using analgesic medicine(6 months after BM-MSC therapy)
- Change in Rutherford classification(6 months after BM-MSC therapy)
- Frequency about using analgesic medicine(6 months after BM-MSC therapy)