An Observational, Practice-Based, Open Label, Feasibility Study to Observe the Efficacy and Safety of Intramuscular Administration of Stempeucel® in Malaysian Patients With Critical Limb Ischemia (CLI) Due to Peripheral Arterial Disease.

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The goal of this observational, practice-based feasibility study is to observe the efficacy and safety of intramuscular administration of Stempeucel® in Malaysian patients with critical limb ischemia (CLI) due to peripheral arterial disease. The main questions it aims to answer are: * Can intramuscular administration of Stempeucel® reduce symptoms of CLI due to peripheral arterial disease while improving the healing rate and functional outcomes? * Does intramuscular administration of Stempeucel® causes any serious adverse events in CLI due to peripheral arterial disease patients? Study patients will be assessed by the PI before administering the Stempeucel® for any other organ with inflammation. The study patients will also be followed up to the duration of 1 year after study treatment administration for safety and efficacy assessment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Patients between 18-65 years old

• Patients diagnosed with atherosclerotic peripheral arterial disease

• Patients not eligible for or have failed surgical or percutaneous revascularization (No option patients)

• Patients with at least one ulcer (between 0.5 to 10 cm2 size)

• Ankle brachial pressure index (ABPI) ≤ 0.6 (toe brachial index (TBI) if ABPI out of range; TBI ≤ 0.5)

• Patients who are able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations

Locations
Other Locations
Malaysia
Hospital Canselor Tunku Mukhriz
RECRUITING
Kuala Lumpur
Contact Information
Primary
Jezamine Lim, PhD
info@cellbiopeutics.com
+60176073103
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 10
Treatments
Experimental: Stempeucel®
Stempeucel® (Ex-vivo cultured MSCs) supplied in 15 ml cryo bags consisting of 200 million or 150 million MSCs, 85% PlasmaLyte-A, 5% HSA and 10% DMSO in a total volume of 15 ml. Following thawing, 35 ml of PlasmaLyte A will be added to the Stempeucel® to make a total volume of 50 ml (Refer section 6.6 IMP Preparation and Designation). The final concentration of components will be 1.5% HSA and 3% DMSO.
Sponsors
Collaborators: Stempeutics Research Pvt Ltd, National University of Malaysia
Leads: Cell Biopeutics Resources Sdn Bhd

This content was sourced from clinicaltrials.gov