A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia

NCT02477540 | Withdrawn Phase 1

• 1 other identifier: Cellgram-CLI
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Ankle Brachial Pressure Index, ABPI

  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.

  6 months after BM-MSC therapy

Secondary Outcomes (9)

• 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

Other Outcomes (2)

• For safety analysis we will observed clinical laboratory tests, physical examinations, tumor marker tests

  12 months after BM-MSC therapy

• occurrence and severity of adverse events

  12 months after BM-MSC therapy

Study Arms (1)

2-time injection group : Cellgram-CLI

EXPERIMENTAL

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.

Drug: Cellgram-CLI

Interventions

Cellgram-CLI DRUG

Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip Main ingredient: Autologous bone marrow-derived mesenchymal stem cells Dosage: 50,000,000 cells/10ml, 2-time injection Storage: An airtight container, 20\~25℃ Injection Method: Intramuscular

Also known as: Autologous bone marrow derived Mesenchymal Stem Cells

2-time injection group : Cellgram-CLI

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients with Stroke or transient ischemic attack within 6 months prior to registration
• Patients tested positive for HIV(Human Immunodeficiency Virus), HCV(Hepatitis C Virus), HBV(Hepatitis B Virus) and Syphilis
• Patients with history of aorta and artery bypass operation, or angioplasty within 2 months recently
• Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia
• Patients with history of cell therapy

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• WoongChol Kang, MD, Ph.D

  Gachon University Gil Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 22, 2015
• Study Start: December 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 22, 2019

Record last verified: 2019-03