Advanced Regenerative Orthopedic Therapies
Stem Cell Therapy at InGeneron
InGeneron, Inc. is a cell therapy device company developing a point-of-care medical device platform for the isolation of adipose-derived regenerative cells (ADRCs) from adipose tissue. ADRCs consist of a heterogeneous population of cells that includes mesenchymal stem cells (MSCs).
The company is actively engaged in FDA-approved clinical trials for the treatment of orthopedic conditions such as rotator cuff tears, wrist
osteoarthritis and facet joint syndrome.
InGeneron’s novel and revolutionary process utilizes autologous ADRCs as a promising therapeutic approach for orthopedic and other indications, providing a safe and cost-effective treatment option.
Challenges
The use of autologous stem cells for patient care in a point-of-care environment has many inherent challenges. One of the main challenges is the ability to quantify accurately and quickly the number and quality of the ADRCs isolated from the InGeneron process and to provide an accurate dose of ADRCs to the patient.
In large multi-site clinical trials, the potential variations in cell counting and viability are a significant concern and can greatly affect clinical outcomes. Different users and instrument-to-instrument variation can both greatly affect the outcome of clinical research.
User Commentary
“We need to use a cell counting device that is FDA-compliant and capable of counting adipose-derived regenerative cells rapidly and efficiently. After testing several options, we found that the NucleoCounter® NC-200™ device fits our required criteria and consistently delivers rapid, reproducible and reliable results.
We did not have to perform any additional validation studies related to cell counting and viability due to the FDA’s familiarity with the instrument. Selecting the NC-200™ as our automatic cell counter saved us time during the FDA application as well as during training of the staff at the clinical sites.
The quality of the device and the excellent customer service that ChemoMetec provides has been a key factor in the successful initiation of our clinical program.”
Glenn Winnier, PhD, Chief Scientific Officer
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