Stem cells injected before amputation aim to prevent further surgery

NCT ID NCT02685098

Disease control Sponsor: Indiana University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether injecting donor stem cells into the leg muscles before amputation could prevent wound problems and reduce the need for more amputations. 81 people scheduled for leg amputation due to poor blood flow took part. The main goal was to check safety, not yet to prove the treatment works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: allogeneic bone marrow derived mesenchymal stem cells
What this could lead to: If it works, this could reduce the need for repeat amputations and improve healing after surgery.
What could go wrong: This is an early phase 1 trial focused on safety, not effectiveness. The results may not lead to a standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

81 people

The number who actually took part.

Started

Jan 2017

Finished

Oct 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be ≥ 40 and ≤90 years of age. 2. Patients requiring lower extremity major amputation, as determined by an independent vascular specialist. 3. If ulceration or gangrene present, it is distal to malleoli (to allow adequate length of ATM area of approximately 3cm x 10cm x 3 cm) 4. Amputation can safely be performed up to 30 days after screening, as determined by an independent vascular or orthopedic surgeon. 5. Females of childbearing potential must be willing to use one form of birth control for the duration of the study. Female participants must undergo a blood or urine pregnancy test at screening. Exclusion Criteria: 1. Patients who are pregnant, planning to become pregnant in the next 12 months, or lactating. 2. CHF hospitalization within the last 1 month prior to enrollment.\* 3. Acute coronary syndrome in the last 1 month prior to enrollment.\* 4. HIV positive, or active, untreated HCV as determined by review of medical records. 5. History of cancer within the last 5 years, except basal cell skin carcinoma 6. Inability to provide written informed consent due to cognitive or language barriers (interpreter permitted). 7. Concurrent enrollment in another clinical investigative trial that may alter the outcomes of enrollment in this trial. 8. Any condition requiring immunosuppressant medications (e.g., for treatment of organ transplants, psoriasis, Crohn's disease, alopecia areata). 9. Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial. * As defined by the standard definitions of CHF and ACS by the American Heart Association.

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Conditions

The condition(s) this trial relates to.

Arterial Occlusive Diseases arteriosclerosis disorder atherosclerosis cardiovascular disorder ischemic disease limb ischemia Pathologic Processes peripheral arterial disease peripheral vascular disease vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation Arterial occlusive disease Arteriosclerosis Atherosclerosis Cardiovascular disease Ischemia Orthopedic procedures Pathologic processes Peripheral arterial disease Peripheral vascular disease Vascular disease

Stem cells injected before amputation aim to prevent further surgery

What the study statuses mean