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 | 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 | 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
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