Nair, H. K. R., Ayyo, A., et al. (2025)
A Quasi-experimental Study of Cellmax™ as an Adjuvant Therapy for Individuals with Chronic Wounds
- Study Design: Quasi-experimental, clinical investigation
- CIP Reference: CELLMAX-23-1.6
- Ethics Reference: NMRR ID-23-00821-PEC
- MDA Notification: MDA/CIU/2024/6370
- Patient Cohort: 88 subjects with complex wounds (DFUs, lymphovascular & traumatic wounds)
Key Results:
- 44,3% complete wound closure (39 patients), 100% epithelialization
- Average time-to-closure: 54 days
- 45% of patients achieved ≥50% wound area reduction
- Progression visible from 4th week after treatment
- Zero adverse events
Publications:
- Wounds Asia 2022 | Vol 5 Issue 3 — “Clinical effect of subcutaneous application of Cellmax™ on treating chronic wounds: a case series”
- Nair et al. (2025) — Full clinical investigation report.
Regulatory Information:
|
Product |
MDA Registration |
MDA License |
|
Cellmax™ Wound Spray |
GD4607326-239804 |
MDA-4519-K123 |
|
Cellmax™ Freeze Dried Powder |
GD8996426-239437 |
MDA-4519-K123 |
Manufacturer: Era Health Care Sdn. Bhd. (1155421-T)
5, Persiaran Industri Bercham 10, Kawasan Perindustrian Ringan Bercham, 31400 Ipoh, Perak
Quality Standards:
- ISO 13485 compliant
- GDPMD compliant
- Biocompatibility tested under ISO 10993 (non-irritant, non-sensitizing)
