Who is sponsoring NCT03241784?

NCT03241784 is sponsored by Stanley H. Appel, MD.

What condition does NCT03241784 study?

NCT03241784 studies ALS (Amyotrophic Lateral Sclerosis).

What drugs are being tested in NCT03241784?

Interventions: Autologous T-regulatory lymphocytes, Interleukin-2.

What is the status of NCT03241784?

NCT03241784 is currently UNKNOWN.

Last reviewed 2018-03-23 · How we verify

Expansion and Infusion of T-Regulatory Cells in Amyotrophic Lateral Sclerosis

NCT03241784 Phase 1 UNKNOWN

This is an open-label pilot study to determine the safety and tolerability of infusions of autologous CD4+ CD25+ regulatory T cells with concomitant subcutaneous IL-2 injections in 4 subjects with ALS.

Details

Lead sponsor	Stanley H. Appel, MD
Phase	Phase 1
Status	UNKNOWN
Enrolment	4
Start date	2016-05-16
Completion	2018-03

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Interventions

Autologous T-regulatory lymphocytes
Interleukin-2

Primary outcomes

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 — Baseline to two years
Clinical laboratory blood tests are standard to assure safety in clinical trials. Complete blood count, chemistry, liver function, throxine (T4) and thyroid stimulating hormone (TSH) will be assessed for normal reference ranges and abnormal (not clinically significant) results. Clinically abnormal results will be documented as adverse events as per CTCAE v4.0.

Countries

United States