Cell Therapy With Mesenchymal Stem Cell in Ischemic Limb Disease

NCT02336646 | Completed Phase 1 DMC

• 1 other identifier: 2012-02-070B
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Bone marrow MSCs will be isolated from allogenic donors, expanded under hypoxic conditions using medium containing no serum or animal-derived reagents, and applies for Phase Ⅰ/Ⅱ study in treating 18 recipients with ischemic limb diseases.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Number of adverse events reported

  6 months

Secondary Outcomes (4)

• Efficacy-The Wong Baker FACES® pain rating scale

  6 months

• Efficacy-Transcutaneous oxygen pressure(TcPO2)

  6 months

• Efficacy-walking distance (TWD)

  6 months

• Efficacy-Ankle Brachial Pressure Index (ABPI)

  6 months

Study Arms (3)

Low Dose Allogenic MSC

EXPERIMENTAL

Low dose allogenic mesenchymal stem cells with IM injection

Drug: Allogenic MSC

High Dose Allogenic MSC

EXPERIMENTAL

High dose allogenic mesenchymal stem cells with IM injection

Drug: Allogenic MSC

Placebo

PLACEBO COMPARATOR

normal saline with Intramuscular injection

Drug: Normal saline

Interventions

Allogenic MSC DRUG

Hypoxia-cultured human bone marrow derived mesenchymal stem cells

Also known as: Biochymal

High Dose Allogenic MSC; Low Dose Allogenic MSC

Normal saline DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• Fontaine stage \> II, total walking distance \< 100 m, stair \< 1 floor, or ulcer / necrosis
• Established critical limb ischemia, clinically and hemodynamically confirmed as per Rutherford- Ⅱ-4, Ⅲ-5, or Ⅲ-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment
• Ankle Brachial Pressure Index (ABPI) ≤ 0.8，ankle pressure ≤ 70 mm Hg, or TcPO2 ≤ 70 mmHg in the foot
• No response to medication (aspirin and cilostazol)
• Normal liver and renal function
• On regular medication for hypertension if any

You may not qualify if:

• The above mentioned patients combined with infection or systemic septicemia. (ps, patients with poor control of diabetes, hypertension and hyperlipidemia will also be excluded
• Patient with Immunocompromised or immunosuppressed
• Type I Diabetes
• Patients having stroke or myocardial infarction within last 3 months
• Hb% \< 10 gm%, Serum Creatinine ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c \> 8%

Sponsors & Collaborators

• Taiwan Bio Therapeutics Inc.: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Saline Solution

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Chun Che Shih

  Taipei Veterans General Hospital, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 13, 2015
• Study Start: May 1, 2015
• Primary Completion: April 27, 2018
• Study Completion: December 20, 2018
• Last Updated: August 25, 2021

Record last verified: 2015-11

Locations

TW (1)