Top 3 clinical trials in regenerative medicine: May 2022
We are pleased to announce that the Dimensions resource on RegMedNet has been updated with the latest clinical trials in regenerative medicine. This month’s top clinical trials include projects on the use of umbilical cord-derived Wharton’s Jelly for the treatment of knee osteoarthritis, the effect of hypoglycemic drugs on the prognosis of spinal surgery in diabetic patients and the impact of the Phoenix Wound Matrix® on the wound microbiome in chronic diabetic foot ulcers. Browse the clinical trials tab in Dimensions to discover the innovative work currently taking place.
Check out this month’s top clinical trials in regenerative medicine:
- Umbilical cord-derived Wharton’s Jelly for treatment of knee osteoarthritis
- A clinical study on the effect of hypoglycemic drugs on the prognosis of spinal surgery in diabetic patients
- A pilot study to determine the impact of the Phoenix Wound Matrix® on the wound microbiome in chronic diabetic foot ulcers
Umbilical cord-derived Wharton’s Jelly for treatment of knee osteoarthritis
Osteoarthritis is the most common joint disorder in the United States, with approximately 67 million people expected to suffer from arthritis by 2030 in the US alone. The current treatment of knee replacement can result in costly revision surgeries, while other methods of treatment such as physical therapy and pharmacological agents have limitations and potential side effects. The goal of this study involving 12 participants is to evaluate the safety and efficacy of intraarticular injection of umbilical cord-derived Wharton’s Jelly as an alternative for the treatment of knee osteoarthritis. Investigators will also hypothesize that patients receiving the treatment will show an improvement in overall satisfaction, numeric pain rating scale, knee injury and osteoarthritis outcome score as well as cartilage formation over a period of 1 year compared to the baseline visit.
Trial Period:
1 Jan 2022 – 31 Dec 2023
Investigators:
Saadiq F. El-Amin III – Principal Investigator, El-Amin Orthopedic & Sports Medicine Institute (GA, USA)
Ashim Gupta – Study Director, BioIntegrate (OH, USA)
Sponsor/Collaborators:
BioIntegrate – Sponsor
A clinical study on the effect of hypoglycemic drugs on the prognosis of spinal surgery in diabetic patients
Diabetes mellitus, characterized by chronic hyperglycemia, is a group of metabolic diseases that seriously harm human health. Diabetes mellitus is present in 5–25% of patients undergoing spine surgery, which poses significant risks in wound infection, delayed healing and wound hematoma, spinal function and stability of internal fixation. Hypoglycemic drugs such as metformin and sitagliptin are widely used treatments to control blood glucose levels and influence the stability of the nerve, bone and internal fixation – this improves the prognosis of spinal surgery in patients with diabetes. The purpose of this study is to examine the effects of these drugs on the long-term prognosis of diabetic patients 1 year after spinal surgery, including quality of life, spinal function and stability of internal fixation. This information can be used to advise patients in need of spinal surgery to choose hypoglycemic drugs, as well as provide patients with diabetes an insight on what to expect following spinal surgery.
Trial period:
7 Feb 2022 – 29 Feb 2024
Investigators:
Yafei Feng – Air Force Medical University (China)
Sponsor/Collaborators:
Xijing Hospital (China) – Sponsor
Air Force Medical University – Location
A pilot study to determine the impact of the Phoenix Wound Matrix® on the wound microbiome in chronic diabetic foot ulcers
This pilot study aims to determine the impact of the Phoenix Wound Matrix®, a fully synthetic and bioabsorbable advanced wound care device, on the wound microbiome in chronic-diabetic foot ulcers. The Phoenix Wound Matrix® provides a temporary microenvironment to support endogenous wound healing, allowing for the regeneration of functional native tissue in the defect space. As the Phoenix Wound Matrix® lowers the pH of the local wound environment. This pilot study will assess the wound microbiome in 10 patients suffering with chronic diabetic foot ulcers, after 1 week of treatment with the Phoenix Wound Matrix®.
Trial period:
15 May 2022 – 1 Jan 2023
Investigators:
Alisha Oropallo – Principal Investigator, Northwell Heath (NY, USA)
Sally Kaplan – Contact, Northwell Heath
Sponsor/Collaborators:
Renovoderm (OH, USA) – Sponsor
Northwell Heath – Collaborator
University of Wisconsin (WI, USA) – Collaborator
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