Abstract
Insufficient oxygen supply represents a relevant issue in several fields of human physiology and medicine. It has been suggested that the implantation of photosynthetic cells can provide oxygen to tissues in the absence of a vascular supply. This approach has been demonstrated to be successful in several in vitro and in vivo models; however, no data is available about their safety in human patients. Here, an early phase-1 clinical trial (ClinicalTrials.gov identifier: NCT03960164, https://clinicaltrials.gov/ct2/show/NCT03960164) is presented to evaluate the safety and feasibility of implanting photosynthetic scaffolds for dermal regeneration in eight patients with full-thickness skin wounds. Overall, this trial shows that the presence of the photosynthetic microalgae Chlamydomonas reinhardtii in the implanted scaffolds did not trigger any deleterious local or systemic immune responses in a 90 days follow-up, allowing full tissue regeneration in humans. The results presented here represent the first attempt to treat patients with photosynthetic cells, supporting the translation of photosynthetic therapies into clinics.Clinical Trial Registration: www.clinicaltrials.gov/ct2/show/NCT03960164, identifier: NCT03960164.
Highlights
Oxygen, the key molecule for aerobic metabolism, is fundamental to several cellular processes including mitochondrial respiration and reactive oxygen species production
Given that oxygen is produced by photosynthetic organisms such as plants and cyanobacteria, the use of photosynthetic cells represents an attractive alternative for local oxygen delivery in vitro and in vivo
For the fabrication of the photosynthetic scaffold, microalgae C. reinhardtii were cultured under sterile conditions, mixed with fibrin and incorporated in a commercially available scaffold for dermal regeneration (Figure 1A)
Summary
The key molecule for aerobic metabolism, is fundamental to several cellular processes including mitochondrial respiration and reactive oxygen species production. The concept of photosynthetic biomaterials was introduced, loading commercially available scaffolds with microalgae, generating oxygen upon light stimulation in vitro [13] This approach was validated in vivo in full thickness animal skin defects, demonstrating its safety and proposing that such oxygenproducing biomaterials could be a promising platform toward autotrophic engineered tissues [14]. In addition to targeted oxygen delivery, photosynthetic microalgae engineered to release recombinant growth factors in situ demonstrated novel utility as vehicles for gene therapies in tissue regeneration in vivo [15, 16]. These developments led to the generation of photosynthetic sutures for local and controlled delivery of oxygen and recombinant growth factors in wounds [17]. As recently demonstrated by an independent group, photosynthetic biomaterials have shown to promote wound healing in diabetic mice [18]
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