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Clinical trial seeks to curb elderly frailty

March 05, 2019 | UCI Health
frail elderly woman with young boy

A slow and shuffling gait, hunched shoulders and the frustrating inability to open jars of food are just a few of the outward signs of frailty — a condition that too often characterizes daily life for people who live into their 80s and beyond.

As frailty develops, so does the risk of:

  • Hospitalization
  • Dependency
  • Disability
  • Death

Trial looks to stop or slow frailty

Currently there are no approved treatments for this condition, which can lead to devastating declines in health. But UCI Health is recruiting participants for a tantalizing new clinical trial to investigate whether stem cell infusions can slow or reverse the descent into frailty.

Dr. Lisa M. Gibbs, director of the UCI Health SeniorHealth Center, is principal investigator for the UCI arm of a national Phase 2b clinical trial taking place at a dozen universities and healthcare organizations across the country. Stem cells play a central role in aging, she says.

“As we age, our bodies produce fewer endogenous stem cells, which are cells that can develop into different types of cells and repair and regenerate tissue or organs,” says Gibbs, professor and chief of geriatric medicine in the UCI School of Medicine’s Department of Family Medicine.

Testing how stem cells migrate

It is this biological slowdown that triggers declines in physiologic health and functional ability.

The study will test whether specially prepared stem cells harvested from adult donors will migrate to injured areas, reduce inflammation and begin repairs in patients exhibiting signs of frailty.

“If we can recognize frailty early, we can potentially slow the progression to disability and dependence,” Gibbs says.

frailty stem cell infographic

What is frailty?

Frailty is characterized by:

  • Unintentional weight loss
  • Exhaustion
  • Weakness
  • Slow walking
  • Low physical activity

It interferes with independent living, makes it harder to recover from stress, may involve impaired cognition and often leads to needing help with daily activities.

Frail people are at higher risk for falls, which is a leading cause of death among the elderly.

Recruitment happening now

The study — run by the life sciences company Longeveron, which is developing biological solutions for aging and aging-associated diseases — aims to enroll 120 total subjects, 10 at UCI. Recruitment is underway at various U.S. study sites for people ages 70 to 85 with mild to moderate frailty who are able to walk 200 to 400 meters in six minutes.

Participants are randomly assigned to four groups of 30 participants each.

Three groups will receive an intravenous infusion of varying amounts of stem cells, and the fourth group will receive an infusion of a placebo. It’s a blind trial, so neither participants nor researchers will know who receives which treatments.

The functional status and medical condition of all participants will be evaluated at intervals from one month to a year.

Study eligibility criteria

About one-quarter to one-third of Americans over age 80 meet the frailty criteria, but potential subjects with an uncontrolled medical condition such as heart disease, hypertension and diabetes, dementia or a recent history of cancer would be excluded.

The research is a natural outgrowth of the SeniorHealth Center’s mission to provide the region’s best care for aging adults with its team of experts and comprehensive, patient-centered approach, Gibbs says. The center’s experts are dedicated to developing new models of care and investigating how to help people live high-quality lives as they age.

“Early studies of stem cell safety showed promise in being able to improve frailty,” she says. “Our goal is to keep people independent as long as possible.”

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