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Application of Stem Cells for Diabetic Foot Wounds

PHRR190709-002163

MMCIRB 2017-143

Unspecified

Evaluation of the Safety and Efficacy of Intramuscular Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells for Diabetic Foot Ulceration

The study hypothesizes that application of Umbilical Cord derived Mesenchymal Stem Cells (UC-MSCs) in the diabetic foot ulcer as an adjunct therapy may accelerate wound healing. It intends to investigate the following:

1. To gather preliminary safety data on the application of intramuscular transplantation of umbilical cord derived mesenchymal stem cells as adjunct treatment for diabetic foot ulceration.

2. To gather preliminary data on the effectiveness of intramuscular transplantation of umbilical cord derived mesenchymal stem cells as an adjunct treatment for diabetic foot ulceration.

This is a pilot study designed as double blinded, randomized, single site interventional study to determine the safety and gather preliminary efficacy data of intramuscular administration of UC-MSCs as an adjunct treatment for diabetic foot ulceration. The control group will receive the standard of care and placebo treatment.

Regime Classification Priority
2017 - 2022 Global competitiveness and innovation in health Drug discovery and development
Start Date Duration in Months Target Completion Date Actual Completion Date
2019-07-30 24 2021-07-30 0000-00-00

Ongoing

Institution Classification Region LTO #
Makati Medical Center Private Business NCR
Institution Region
Philippine Council for Health Research and Development, Department of Science and Technology NCR
Name E-Mail Institution and Institution Address
Marviel T. Berboso, RN inquiry.ctc@makatimed.net.ph Center for Regenerative Medicine, 6th Floor, Tower 2, Makati Medical Center, #2 Amorsolo Street, Legaspi Village, Makati City, Philippines 1229
Name E-Mail Institution and Institution Address
Jayson S. Santiago jayson.santiago@makatimed.net.ph Center for Regenerative Medicine, 6th Floor, Tower 2, Makati Medical Center, #2 Amorsolo Street, Legaspi Village, Makati City, Philippines 1229
Name Expertise Affiliation
Jose Maria Avila, MD Pathology Makati Medical Center
Project Location Institutional Ethics Review Board
Makati Medical Center Makati Medical Center Institutional Review Board

Diabetic Foot Ulceration

Outcome Name: Safety

Metric/Method of Measurement: Participant reporting of Adverse Events

Timepoint: 1-4 months post-treatment

 

Outcome Name: Foot Wound Size

Metric/Method of Measurement: Wound Area Measurement

Timepoint: 1-4 months post-treatment

 

Outcome Name: Ankle-Brachial Indes

Metric/Method of Measurement: Doppler Instrument

Timepoint: 1-4 months post-treatment

 

Outcome Name: Resting Pain

Metric/Method of Measurement: Resting Pain Scale

Timepoint: 1-4 months post-treatment

 

Outcome Name: Quality of Life

Metric/Method of Measurement: Rand Short Survey Form

Timepoint: 1-4 months post-treatment

Recruiting

  • Philippines

Clinical Trial

MMCIRB 2017-143

Unspecified

2019-05-21

0000-00-00

30

Unspecified

Unspecified

2019-07-30

Age above 21 and below 70 years; non-healing ulcers that do not show reduction in size (with less than 40% of wound closure) during 1-3 months of current standard care for diabetic foot ulcer by a wound care specialist; maximum of three (3) unilateral or bilateral wounds located in no more than one zone (foot, ankle or leg); grade 1 or 2 ulcer on the Wagner scale; strict diabetes control with HbA1c ≤ 8.0%; no surgical or radiological interventional option for revascularisation as confirmed by a vascular surgeon; subjects had adequate circulation to ulcer as documented by: palpation of pulses around ulcer using Doppler exam; ABI values ranging between 0.5 and 1.3; normal serum albumin ranging between 35-45 g/L and, negative pregnancy test when applicable.

Interventional

Umbilical Cord Tissue Derived Mesenchymal Stem Cells

Unspecified

None

Randomized

Double Blind

Unspecified

Parallel

The study hypothesizes that application of UC-MSCs in the diabetic foot ulcer as an adjunct therapy may accelerate wound healing.

Phase I

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
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