HOUSTON--(BUSINESS WIRE)-- 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 pivotal trial in the same indication.

Publication Details

DOI: https://dx.doi.org/10.4252/wjsc.v13.i7.944

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 has developed the Transpose^® RT System, which consists of a processing unit, a set of disposables and Matrase™, a unique enzyme mixture. The system allows isolation of UA-ADRCs from patients' own adipose tissue at point of care within approximately one hour. The UA-ADRCs are administered into the defect by injection under ultrasound guidance.

The Transpose^® RT System is currently being investigated under FDA IDE approval and accessible for research use only in the US. Currently, InGeneron has several active, FDA approved clinical trials utilizing the Transpose^® RT System that are enrolling. More information on these clinical trials can be found at www.clinicaltrials.gov under the identifiers NCT03752827, NCT03513731, and NCT03503305.

About InGeneron

InGeneron is a clinical stage cell therapy company enabling novel, safe and evidence-based regenerative medicine therapies. Our purpose is to set new therapeutic standards by developing treatments that unlock the healing potential of each patient’s own regenerative cells processed at the point of care for same-day application. We focus on helping patients who are impacted by musculoskeletal indications and are pursuing research to extend the application of our platform technology to additional treatment areas.

www.ingeneron.com

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