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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01302015
Other study ID # Vascostem
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2007
Est. completion date December 2013

Study information

Verified date June 2019
Source R-Bio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with Buerger's disease.


Description:

Buerger's disease, also known as thromboangiitis obliterans, is a rare disorder that, in most cases, affects young or middle-aged male cigarette smokers. It is characterized by narrowing or blockage (occlusion) of the veins and arteries of the extremities, resulting in reduced blood flow to these areas (peripheral vascular disease). The exact cause of Buerger's disease is not known; however, most affected individuals are heavy tobacco users.

This drug is an autologous cell treatment for necrosis in the legs of patients with Beurger's diseases to improve symptoms through vascular regeneration.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Subjects who understand and sign the consent form for this study.

- Age :20-80, males and females

- Patients at least 6 months after Buerger's disease

- Patients with a luminal stenosis of more than 50% on angiography

- Rutherford class II-4, III-5 or III-6

- Subjects not eligible to undergo a revascularization or vascular bypass graft

- Patients who can't treat with traditional medication and need a arthroplasty.

- Patients whose lesion is 2~6 cm2 in size

- Duration of pain over Grade 4(11-point numeric scale) : > 4 months

Exclusion Criteria:

- Subjects who cannot survive more than 6 months with critical other complications.

- Patient with well-known active malignant tumor.

- Patients who exceed normal reference values from following test : PAP smear screening, chest X-ray, PSA, mammogram, occult blood test

- Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia

- Patients with uncontrolled iliac artery obstruction of targeted areas.

- Condition with targeted lower limb that have widespread necrosis or in need of amputation.

- End-stage renal failure patients who depend on hemodialysis

- Patients with uncontrolled diabetes mellitus (HbA1c > 10%).

- Treatment with immunosuppressant (prednisone > 5mg/day).

- Treatment with a anti-inflammatory drugs within 1 weeks prior to enrollment.

- Women who are pregnant or breast feeding or planning to become pregnant during the study.

- Subjects who have cerebrovascular accident within 6 months prior to inclusion in the study.

- Patients with acute myocardial infarction, angina pectoris.

- Subjects who had been underwent a cardiovascular surgery such as carotid endarterectomy, arterial aneurysm, bypass surgery and coronary bypass surgery within 3 months prior to inclusion in the study.

- Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study.

- Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
RNL-Vascostem®


Locations

Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul
Korea, Republic of SMG-SNU Boramae Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
R-Bio

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Treadmill Walking Distance Improvement in TWD(Treadmill Walking Distance) 24 weeks
Secondary VAS(Visual Analog Scale) Improvement in VAS(Visual Analog Scale) score 24 weeks
Secondary Toe-Brachial Pressure Index, TBPI Improvement in TBPI score 24 weeks
Secondary Transcutaneous oxygen pressure, TcPO2 Improvement in TcPO2 score 24 weeks
Secondary Arterial Brachial Pressure Index, ABPI Improvement in ABPI score 24 weeks
Secondary Pain Free Walking Distance, PFWD Improvement in PFWD score 24 weeks
Secondary Angiography Improvement on Angiography 24 weeks
Secondary Laser Doppler Improvement on Laser Doppler 24 weeks
Secondary dose and frequency in use of a analgesic medicine Changes in dose and frequency in use of a analgesic medicine 24 weeks
Secondary Safety Evaluation To determine the overall safety of RNL-VascoStem® carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests 24 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01446055 - Safety and Efficacy Study of Autologous BM-MNC Processed by Two Methods for Treating Patients With Chronic Limb Ischemia Phase 1/Phase 2
Completed NCT01484574 - A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease Phase 2
Recruiting NCT05854615 - Efficacy and Safety of Stempeucel® in Patients With Critical Limb Ischemia (CLI) Due to Buerger's Disease Phase 4