Stem Cell Therapy for Lung and Kidney Disease: Regend Therapeutics’ Progress Explained

Stem cells could do more than manage disease — they may help repair it. Here’s a simple look at Regend Therapeutics’ latest clinical progress and funding news.

Stem Cell Therapy for Lung and Kidney Disease: Regend Therapeutics’ Progress Explained

Most treatments for serious conditions like COPD or kidney disease can only slow the damage — they cannot reverse it. Regend Therapeutics, a Chinese regenerative medicine company, is working to change that using stem cells. The company recently raised RMB 350 million (around USD 48 million) to push its therapies further through clinical trials, and early results are showing real promise.

Who Is Regend Therapeutics?

Founded in 2015, Regend Therapeutics focuses on using progenitor cells — the body’s own natural repair cells — to regenerate damaged organs. These cells behave similarly to stem cells but work in a more targeted way, making them well-suited for treating specific organ damage.

The company’s two lead therapy candidates are:

• REGEND001 — targets damaged lung tissue in patients with COPD and pulmonary fibrosis
• REGEND003 — targets damaged kidney tissue in patients with diabetic kidney disease

Both therapies use cells taken from the patient’s own body, which reduces the risk of rejection.

The Funding and What It Will Be Used For

Seven new investors joined this round, including Yuze Capital and Hefei High-Tech Investment, alongside returning investors Fir Creek Capital and Tasly Capital. The funds will go toward advancing clinical trials, expanding internationally, and building production facilities to prepare for eventual market entry.

REGEND001: Rebuilding Damaged Lungs

The Problem With Current Lung Disease Treatments

COPD and IPF are progressive lung diseases with no cure. Existing treatments mainly slow the decline — they cannot restore lung tissue that has already been lost.

How REGEND001 Works

The therapy collects basal stem cells from a healthy section of the patient’s own airway, expands them in a laboratory, then redelivers them into the lungs via a thin flexible tube. The goal is for these cells to stimulate the growth of new, healthy lung tissue.

Early clinical data shows patients experienced improved lung function, better quality of life, and measurable increases in lung volume — suggesting actual tissue repair is taking place. Phase 3 trials in China are planned for 2026.

A refined version called Pulmovinci has also received FDA Orphan Drug Designation for IPF in the United States — a regulatory recognition that supports its continued development for this rare condition.

REGEND003: Repairing Kidneys Without Invasive Procedures

Diabetic kidney disease affects over 30% of all chronic kidney disease patients — a group projected to exceed one billion people globally by 2030. Current treatments cannot restore kidney tissue that has been lost.

REGEND003 collects kidney progenitor cells from the patient’s urine — no needle or biopsy required. These cells are then used to help regenerate the kidney’s filtering units. Preclinical studies showed improvements in kidney function markers, and the therapy has now entered Phase 1 clinical trials with its first patient group enrolled.

Already Treating Patients in Hainan

In early 2025, REGEND001 became one of the first stem cell therapies approved for supervised clinical use in China’s Hainan Boao Lecheng International Medical Pilot Zone — a government-designated area where innovative treatments can be offered to patients before full national approval. Since May 2024, over 140 patients have been treated at RMB 150,000 per treatment.

This pilot has also helped the company demonstrate that stem cell therapies can work within a real healthcare and payment system — an important step for the industry’s long-term commercial viability.

Conclusion

Regend Therapeutics is making steady, evidence-backed progress in an area of medicine that has long been difficult to treat. With real patients already being treated, Phase 3 trials on the horizon, and international regulatory recognition for its lung therapy, the company represents a meaningful step forward in stem cell research. The science is not finished — but it is moving in a clear and promising direction.