Comprehensive immunohistochemical analysis of human tendon biopsy provides strong evidence of regeneration in patient with traumatic rotator cuff injury
Houston, TX, July 23, 2021 – InGeneron, Inc., a clinical stage regenerative medicine and cell therapy company, today announced the publication of the first-in-human comprehensive immunohistochemical evaluation of adult tendon repair following the local injection of fresh, uncultured, unmodified, autologous, adipose derived regenerative cells (UA-ADRCs). This newly-released research paper, titled “First Immunohistochemical Evidence of Human Tendon Repair Following Stem Cell Injection: A Case Report and Review of Literature“, was published in the World Journal of Stem Cells on July 23, 2021 (DOI: https://dx.doi.org/10.4252/wjsc.v13.i7.944). The publication provides detailed analysis of a tendon biopsy taken from a 66-year-old patient 10 weeks after his own stem cells were harvested and injected into his damaged shoulder tendon using InGeneron’s Transpose® RT System. The analysis strongly indicates regenerative healing of the tendon, resulting from transformation of UA-ADRCs into new tendon tissue.
The novel findings of the study illuminate cellular mechanisms behind the regenerative properties of UA-ADRCs, including indirect evidence that descendants of UA-ADRCs integrated into the host tissue, as well as provide supportive evidence for the healing potential of autologous cell therapy. Importantly, the investigated tendon showed evidence of histological regeneration without scar formation, a finding indicating significant advantages over existing treatments options.
For 15 years, InGeneron has conducted numerous animal and human studies documenting positive health outcomes from regenerative cell therapies. However, only a few studies have documented the underlying mechanisms of the treatment. The now available publication states that “to our knowledge, this is the first report demonstrating regenerative healing without scar formation of a partial-thickness tear in a human tendon following injection of UA-ADRCs.” These findings are encouraging to experts in the field seeking insight into the mechanism of action. Dr. Nicola Maffulli, a leading expert in tendon repair with over 1,000 peer reviewed publications, explains, “normally, damaged tendons heal by producing scar tissue, which works as a patch for the partial tear but also inherently limits the functionality of the tendon. The microscopic images of the tendon treated with stem cells clearly demonstrate that a different type of healing had taken place. The formation of new tendon tissue and the absence of scar tissue are regenerative processes we typically only observe in fetal tendons.” Dr. Maffulli was not involved in the study and is not affiliated with InGeneron.
“Hundreds of thousands of patients in the United States suffer from orthopedic injuries that are not effectively addressed by current treatment options,” says Christopher Alt, Director of Scientific and Medical Affairs at InGeneron. “Pain medication and corticosteroid injections only provide temporary relief, and invasive surgical intervention might often do more harm than good. By providing a point of care treatment able to be performed in under 3 hours, our goal is to offer an effective, safe, and efficient alternative for the many patients whose needs are not properly addressed by this status quo.”
This clinical case report highlights the disease-modifying potential of InGeneron’s cell therapy for the treatment of symptomatic, partial-thickness rotator cuff tears, one of the most prevalent shoulder disorders in adults. These findings provide support to InGeneron’s ongoing FDA approved pivitol trial in the same indication.
Citation: Alt E, Rothoerl R, Hoppert M, Frank HG, Wuerfel T, Alt C, Schmitz C. First immunohistochemical evidence of human tendon repair following stem cell injection: A case report and review of literature. World J Stem Cells 2021; 13(7): 944-970
About the Transpose® RT System and FDA approved clinical trials
InGeneron’s Transpose® RT cell therapy platform consists of a processing unit, a set of disposables and Matrase®, a proprietary enzyme mixture. The platform allows the isolation of regenerative cells from the patients’ own adipose tissue at point-of-care in less than 90 minutes for same-day treatment. The cells are re-administered into the patient’s damaged tissue by injection under ultrasound or fluoroscopic guidance.
The Transpose® RT System is being investigated in several FDA-approved clinical trials and is currently available in the U.S. for research use only. More information on InGeneron’s actively enrolling clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.
InGeneron is a clinical-stage biotechnology company developing novel, safe, and evidence-based cell therapies. We are setting new therapeutic standards by enabling minimally invasive treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day treatment. We currently focus on helping patients impacted by orthopedic conditions and are conducting several clinical trials to validate our technology as a disease-modifying treatment. Based on more than 20 years of research, InGeneron is dedicated to developing therapies supported by clinical evidence and approved by the FDA.
Eckhard Alt, MD, PhD
Executive Chairman of InGeneron
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