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REGENECYTE® for Long COVID is StemCyte's Phase II clinical program studying allogeneic cord blood-derived hematopoietic progenitor cell therapy for post-COVID syndrome, registered as ClinicalTrials.gov NCT05682560. The investigational use of REGENECYTE® in Long COVID has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation, and FDA cleared an Expanded Access Program in January 2026 to allow eligible patients to receive treatment outside the trial setting.

HPC, Cord Blood · Long COVID Program

Long COVID Clinical TrialPhase IIa · Peer-Reviewed Results

Cord blood cell therapy (HPC, Cord Blood) produced statistically significant, durable fatigue reduction in patients with post-COVID syndrome in a randomized, placebo-controlled trial published in The Lancet's EClinicalMedicine.

Full Study (Lancet) Clinical Research →
85%
Fatigue Resolution at Week 26
85%
Treatment
20%
Placebo
HPC, Cord Blood
Therapy
PASC / Long COVID
Condition
Phase IIa Complete
Trial Phase
RMAT + EAP Cleared
FDA Status
Jan 2026
EClinicalMedicine

Efficacy Results

In a 30-patient, randomized, placebo-controlled study (NCT05682560), patients treated with cord blood cell therapy showed significant improvement in chronic fatigue, the most debilitating feature of post-COVID syndrome. The Chalder Fatigue Questionnaire (CFQ-11) measured fatigue severity at weeks 6, 12, 18, and 26.

Fatigue Resolution at Week 26
Patients achieving CFQ-11 score <4 (complete fatigue resolution)
HPC, Cord Blood
85%
Placebo
20%
p<0.01, Statistically significant difference between treatment and placebo groups

Statistically significant improvements were observed at all measured timepoints: week 6 (p<0.001), week 12 (p<0.001), week 18 (p<0.001), and week 26 (p=0.004). Physical fatigue severity also improved significantly. The Patient Global Impression of Severity (PGI-S) scale confirmed durable symptom relief.

Fatigue Improvement Over Time
CFQ-11 significance vs placebo at each timepoint (wider = more significant)
Week 6
p<0.001
Week 12
p<0.001
Week 18
p<0.001
Week 26
p=0.004

Safety Profile

The trial met its primary safety endpoint. In the treatment group, 2 of 20 participants (10%) experienced mild, transient adverse events. All resolved within one hour. No severe adverse events were observed. The placebo group had a 20% TEAE rate, with events unrelated to treatment.

Cognitive Function

Montreal Cognitive Assessment (MoCA) scores showed slight improvement from baseline (24 to 26) in the treatment group, though the difference was not statistically significant.

Regulatory Pathway

RMAT Designation (October 2024)

The FDA granted Regenerative Medicine Advanced Therapy designation for HPC, Cord Blood in Long COVID, enabling accelerated development and priority review. As of 2026, REGENECYTE® is the only FDA-licensed cord blood product under evaluation in a U.S. clinical trial for Long COVID.

Expanded Access Program (January 2026)

The FDA cleared a compassionate use pathway for patients with serious or life-threatening Long COVID symptoms who have exhausted standard treatment options. StemCyte works directly with treating physicians to facilitate access.

As reported by AABB →

Phase III (Preparing)

Following a positive End-of-Phase 2 meeting with the FDA in March 2025, StemCyte received guidance supporting the design of a pivotal Phase III trial. The agency's recommendations may reduce participant requirements and shorten the overall timeline.

Implications for Cord Blood Science

This study demonstrates that cord blood-derived HPCs may have broader therapeutic applications beyond hematopoietic reconstitution, potentially addressing chronic inflammatory and post-infectious conditions. These findings support further clinical development targeting fatigue in post-COVID and potentially other fatigue-related conditions.

Sources: eClinicalMedicine (2026) 91:103737. StemCyte press release, Jan 26, 2026. AABB, Feb 4, 2026. ClinicalTrials.gov NCT05682560.

Trial Details

DesignRCT, Placebo-Controlled
BlindingSingle-Blind
Randomization2:1 (Treatment:Placebo)
Participants30
Infusions3 IV doses
Follow-up26 weeks
RegistryNCT05682560

Key Outcomes

Primary (Safety)Met ✓
Fatigue CFQ-11p<0.01 ✓
PGI-SSignificant ✓
MoCA (Cognition)Improved (NS)

Timeline

2022FDA trial approval
Oct 2024RMAT designation
Dec 2024Phase IIa unblind
Jan 2026Lancet publication
Jan 2026EAP cleared
NextPhase III

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Frequently asked questions

A 30-patient randomized, placebo-controlled trial (NCT05682560) evaluated repeated intravenous infusions of REGENECYTE® (HPC, Cord Blood) for chronic fatigue in post-COVID syndrome. Fatigue severity was measured by the Chalder Fatigue Questionnaire (CFQ-11) and the Patient Global Impression of Severity (PGI-S) scale at weeks 6, 12, 18, and 26.

85% of REGENECYTE® recipients achieved complete fatigue resolution at week 26, compared to 20% in the placebo group. CFQ-11 and PGI-S endpoints reached statistical significance at every measured timepoint (week 6 p<0.001, week 12 p<0.001, week 18 p<0.001, week 26 p=0.004). Results were published in eClinicalMedicine (The Lancet) on January 9, 2026.

No. REGENECYTE® is investigational for post-COVID syndrome. The FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation in October 2024 and cleared an Expanded Access Program in January 2026 for patients with serious or life-threatening Long COVID symptoms who have exhausted standard treatment options.

Through the FDA-cleared Expanded Access Program. Requests must be initiated by a treating physician and follow FDA expanded-access regulations. Eligibility, supply, and case review are evaluated on a per-patient basis.

A Phase III trial is in preparation. Following a positive End-of-Phase 2 meeting with the FDA in March 2025, StemCyte received guidance supporting the pivotal trial design.

Advancing cord blood therapy for Long COVID

Phase IIa completed. Expanded Access cleared. Phase III in preparation.

Contact clinical team